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Completed

NCT Number: NCT03327571

B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes

The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.

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Key information

Conditions

Classical Hodgkin Lymphoma Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Relapsed or Refractory Classical Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Hospital

Busan, 49241, South Korea

About this study

This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.

The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

Group 1: cHL Group 2: RRHL

This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013.
  • Age greater than or equal to (>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
  • Alive or deceased.
  • Written informed consent is obtained for study data collection, where necessary, according to local regulations.

Exclusion criteria

  • Participants for whom the minimum study dataset is not available from their hospital medical records.
  • Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.

Treatment and study plan

Primary outcomes

  1. Group 2, RRHL: Progression Free Survival (PFS)

    Time frame: From initiation of first treatment until first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. Progressive disease (PD) was defined as any new lesion or increase by >=50% of previously involved site from nadir, and was evaluated based on International Working Group (IWG) criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.

Secondary outcomes

  1. Group 1, cHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis

    Time frame: Day 1 at cHL diagnosis

    The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 percent [%] of body weight over 6 months).

  2. Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Diagnosis

    Time frame: Day 1 at RRHL diagnosis

    The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (lessspread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10 % of body weight over 6 months).

  3. Group 2, RRHL: Number of Participants Based on Clinical Staging According to Ann Arbor Staging at Relapse After First Relapse or Refractory Diagnosis

    Time frame: At second, third, fourth, and fifth relapse (up to 9 years 10 months)

    The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). Additional sub staging variables include: A, asymptomatic; and B, presence of B symptoms (including fever, night sweats and weight loss of >=10% of body weight over 6 months).

  4. Group 1, cHL: Number of Participants Based on Each International Prognostic Score (IPS) Category

    Time frame: Day 1 at cHL diagnosis

    IPS score was calculated based on following factors: age >=45 years, male sex, stage IV disease, albumin<4 gram per liter (g/L), white blood cell (WBC)>=15*10^9 per liter (/L), haemoglobin <10.5 g/L, and lymphocyte count<0.6*10^6/L or <8% of differential. One point was assigned for each of above factors. The sum of points allotted correlates with following risk groups: good risk (0-1 points)-5 year survival of 89-90%; fair risk (2 to 3 points)-5 year survival of 78-81%; poor risk (4-7 points)-5 year survival of 56-61%. Total score range is 0 to 7, lower scores indicate higher survival rate.

  5. Group 1, cHL: Number of Participants With B Symptoms at Diagnosis

    Time frame: Day 1 at cHL diagnosis

    The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.

  6. Group 2, RRHL: Number of Participants With B Symptoms at Diagnosis

    Time frame: Day 1 at RRHL diagnosis

    The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (B-symptoms) are present, a "B" classification is added to the stage: fever, night sweats and weight loss of >=10% of body weight over 6 months. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas.

  7. Group 2, RRHL: Number of Participants Categorized Based on Prior Therapies for Hodgkin Lymphoma (HL) at Each Line of Treatment

    Time frame: Day 1 at RRHL diagnosis

    Number of participants were categorized based on prior therapies for HL at each line of treatment.

  8. Group 2, RRHL: Median Number of Previous Treatment Regimens (Chemotherapies) Received

    Time frame: Day 1 at RRHL diagnosis

  9. Group 1, cHL: Number of Participants Categorized Based on Frontline Treatment Regimens

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: Doxorubicin (Doxo) + Bleomycin (bleo) + Vinblastine (Vinbl) + Decarbazine (Dacar) (ABVD); 3: Doxo + Vinbl + Mechlorethamine + Etoposide (Eto) + Vincristilne (Vinc) + Bleo + Prednisone (Pred) (Stanford V); 6: Cyclophophamide (Cyclo) + Vinc + Procarbazine (Procarb) + Pred (C-MOPP); 7: Dexamethasone + Cytarabine + Cisplatin (DHAP); 8: Eto + Methylprednisolone + Cytarabine + Cisplatin (ESHAP); 10: Ifosfamide+ Carboplatin + Eto (ICE); 11: Ifosfamide + Gemcitabine +Vinorelbine + Pred (IGEV); 17: Rituximab; 18: Brentuximab vedotin; 4: Bleo + Eto + Doxo + Cyclo + Vinc + Procarb + Pred (BEACOPP); 14: Cycl + Doxo + Vinc + Pred (CHOP); 15: Cycl + Vinc + Pred (CVP); 2: ABVD + Doxo + Bleo + Vinbl + Dacar then Bleo + Eto + Doxo + Cycl + Vinc + Procarb+ Pred ( Escalated BEACOPP); 24: Other.

  10. Group 1, cHL: Median Number of Treatment Cycles Associated With Each Frontline Treatment Regimen

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 17: Rituximab; 18: Brentuximab vedotin; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD + Escalated BEACOPP; 24: Other.

  11. Group 1, cHL: Number of Participants Who Received Treatments for HL After Completion of Frontline Therapy (Before Relapse)

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 10: ICE; 11: IGEV; 12: Carmustine + Cytarabine + Etoposide + Melphalan (Mini-BEAM); 13: Etoposide + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 16: Gemcitabine + Vinoreilbine + Pegylated liposomal doxorubicin (GVD); 4: BEACOPP; 14: CHOP; 24: Other.

  12. Group 1, cHL: Number of Participants Based on Radiotherapy (RT) Type and Site When Received at Frontline

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  13. Group 1, cHL: Number of Participants Categorized Based on RT Treatment Given as Pre-planned Frontline Treatment and RT Treatment Given for Residual Fluorodeoxyglucose (FDG)-Avid Disease

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Assessment was done for RT's whether used for pre-planned frontline treatment or for residual Fluorodeoxyglucose (FDG)-avid disease.

  14. Group 2, RRHL: Percentage of Participants Categorized Based on ASCT Eligibility Assessment

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  15. Group 2, RRHL: Median Number of Treatment Cycles Associated With Relapse/ Refractory Treatment Regimen for ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 8: ESHAP; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 22: Nivolumab; 24: Other.

  16. Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Reasons for Not Undergoing ASCT Despite Being ASCT Eligible

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Reasons for ASCT-eligible participants for not undergoing ASCT included participant refusal, inability to mobilize stem cells, loss of response to chemotherapy, cumulative toxicities, comorbid conditions, others, and unknown.

  17. Group 2, RRHL: Number of Non-ASCT Participants Based on Reasons for ASCT Ineligibility

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Reasons for ASCT ineligibility included advanced age, comorbid conditions, chemoresistant disease, cumulative toxicities, and others.

  18. Group 2, RRHL: Number of Non-ASCT Participants Categorized Based on Treatment Regimens Received at Each Line of Treatment

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 2: ABVD followed by Escalated BEACOPP; 3: Stanford V; 4: BEACOPP; 6: Cyclophosphamide C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: MINE; 14: CHOP; 15: CVP; 16: GVD; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 23: Pembrolizumab; 24: Other. More than one line of treatment or therapy was selected for each participant.

  19. Group 2, RRHL: Percentage of Non-ASCT Participants for Whom Treatment is Palliative

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  20. Group 2, RRHL: Percentage of Non-ASCT Participants Receiving Positron Emission Tomography (PET) or Computed Tomography (CT) at Each Line of Treatment Pathway

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  21. Group 2, RRHL: Percentage of Non-ASCT Participants Receiving RT at Each Line of Treatment Pathway

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  22. Group 2, RRHL: Median Frequency of PET or PET-CT Scan Assessment for Non-ASCT Participants

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  23. Group 2, RRHL: Median Number of Treatment Cycles Received in Each Treatment Regimen at Each Line of Treatment in Non-ASCT Participants

    Time frame: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 19: Bendamustine; 4: BEACOPP; 13: MINE; 14: CHOP; 24: Other; 8: ESHAP; 9: Gemcitabine + Carboplatin + Dexamethasone (GCD); 10: ICE; 17: Rituximab; 18: Brentuximab vedotin; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 22: Nivolumab; 16: GVD; 21: Lenalidomide; 24: Other.

  24. Group 2, RRHL: Duration of Each Line of Treatment in Non-ASCT Participants

    Time frame: From initiation of first treatment until first documentation of relapse/PD/until date of death( or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  25. Group 2, RRHL: Percentage of Non-ASCT Participants Categorized Based on Dose Delays in Each Treatment Regimen at Each Line of Treatment

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 3: Stanford V; 6: C-MOPP; 7: DHAP; 11: IGEV; 4: BEACOPP; 14: CHOP; 15: CVP; 2: ABVD followed by Escalated BEACOPP; 24: Other; 8: ESHAP; 9: GCD; 10: ICE; 13: MINE; 17: Rituximab; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab. More than one line of treatment or therapy was selected for each participant

  26. Group 2, RRHL: Time From Relapse (After Frontline Treatment) to First Treatment Post-relapse in Non-ASCT Participants

    Time frame: From relapse after frontline treatment to first treatment post-relapse or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  27. Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From Relapse and Completion of Previous Treatment in Non-ASCT Participants

    Time frame: From both relapse and from completion of previous treatment to initiation of each subsequent treatment (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  28. Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site Received at Frontline

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  29. Group 2, RRHL: Number of Participants With Non-ASCT Assessed for RT Type, Site at Relapse/ Refractory

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  30. Group 2, RRHL: Total Dose of Radiotherapies in Non-ASCT Participants

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  31. Group 2, RRHL: Number of PET or CT Scan Assessments

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  32. Group 2, RRHL: Number of Participants Categorized Based on Various Chemotherapeutic Regimen and Therapies Used in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 8: ESHAP; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 16: GVD; 24: Other. Conditioning regimens are BEAM (Carmustine + Etoposide + Cytarabine + Melphalan), CBV (cyclophosphamide + Carmustine + vp16) BeEAM (bendamustine) and Gemcitabine/Busulfan/Melphalan.

  33. Group 2, RRHL: Number of Participants Categorized Based on With Known Risk Factors for Relapse Post ASCT in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Known risk factors for relapse after ASCT included time to first relapse less than or equal to (<=) 3 months, stage IV disease at relapse, bulky disease >=5 centimeter (cm) at relapse, extranodal disease, inadequate response to salvage chemotherapy (partial remission [PR] or PET positivity), performance status (eastern Cooperative oncology group [ECOG]) >=1. The ECOG assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities).

  34. Group 2, RRHL: Median Number of Cycles Associated With Each Salvage Regimen in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 6: C-MOPP; 7: DHAP; 8: ESHAP; 9: GCD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 13: Eto + Ifosfamide + Mesna + Mitoxantrone (MINE); 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab; 16: GVD; 4: BEACOPP; 14: CHOP; 2: ABVD + Escalated BEACOPP; 24: Other.

  35. Group 2, RRHL: Percentage of Participants Receiving Consolidation Therapy Post-ASCT in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  36. Group 2, RRHL: Median Duration of Treatment for Consolidation Therapies Used in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  37. Group 2, RRHL: Number of Participants Categorized Based on Source of ASCT Procedures in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  38. Group 2, RRHL: Median Time From Relapse (After End of Frontline Treatment) to ASCT in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  39. Group 2, RRHL: CD34+ Count Administered in Participants Undergoing ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  40. Group 2, RRHL: Time From ASCT to First Relapse in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  41. Group 2, RRHL: Number of Participants Categorized Based on Post-ASCT Regimens Received at Each Line of Treatment in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 22: Nivolumab; 23: Pembrolizumab; 16: GVD, 9: GCD; 24: other; 19: Bendamustine; 14: CHOP; 17: Rituximab.

  42. Group 2, RRHL: Percentage of Participants Who Relapse After ASCT Categorized Based on Palliative Therapy Regimens

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 9: GVD; 10: ICE; 11: IGEV; 12: Mini-BEAM; 18: Brentuximab vedotin; 19: Bendamustine; 22: Nivolumab.

  43. Group 2, RRHL: Number of Cycles Received at Each Line of Treatment for Each Treatment Regimen in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Therapy regimens were numbered as 1: ABVD; 7: DHAP; 10: ICE; 11: IGEV; 4: BEACOPP; 2: ABVD followed by Escalated BEACOPP; 8: ESHAP; 12: Mini-BEAM; 13: MINE; 18: Brentuximab vedotin; 9: GCD; 22: Nivolumab; 23: Pembrolizumab; 16: GVD.

  44. Group 2, RRHL: Duration of Each Line of Treatment for Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  45. Group 2, RRHL: Time From ASCT to First Treatment After Relapse in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  46. Group 2, RRHL: Time to Initiation of Each Subsequent Treatment, From ASCT and From Completion of Previous Treatment in Participants Who Relapse From ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  47. Group 2, RRHL: Percentage of Participants Who Received PET-CT Scan, CT Scan and Radiotherapy at Each Stage of the Treatment Pathway in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse/or refractory, and radiotherapy was assessed for frontline and relapse/refractory, as planned.

  48. Group 2, RRHL: Mean Frequency of PET or PET-CT Scan Assessments for Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Data for PET-CT scan and CT scans were assessed for baseline, frontline and relapse or refractory, as planned.

  49. Group 2, RRHL: Number of Participants With Types of Radiotherapies Received at Frontline and at Relapse/Refractory in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis and until death or date of data collected, whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  50. Group 2, RRHL: Number of Participants Categorized Based on Anatomical Site of Radiotherapies in Participants Who Relapse After ASCT at Frontline and at Relapse/Refractory

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  51. Group 2, RRHL: Number of Participants Categorized Based on Intent of Treatment of Radiotherapies in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  52. Group 2, RRHL: Total Dose of Radiotherapies Received at Frontline and Relapse/Refractory in Participants Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  53. Group 2, RRHL: Percentage of Participants Undergoing Subsequent ASCTs and Allogeneic Stem Cell Transplantation (Allo-SCT)

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  54. Group 2, RRHL: Group 2, RRHL: Median Number of ASCTs for Each Participant Who Relapse After ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  55. Group 1, cHL: Median PFS

    Time frame: From initiation of frontline regimen to first documentation of relapse/PD/until date of death (or date when participant was last alive), whichever occurred first (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    PFS was defined as time from initiation of frontline regimen to first documentation of relapse or disease progression or death, censored at date of most recent follow-up/contact. PD was defined as any new lesion or increase by >= 50% of previously involved site from nadir, and was evaluated based on IWG criteria (Cheson et al 2007). Median PFS was estimated using the Kaplan-Meier method.

  56. Group 1, cHL: Number of Participants Based on Best Clinical Response Post Completion of Frontline Treatment

    Time frame: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Best clinical response as complete remission (CR), partial remission (PR), stable disease (SD), or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.

  57. Group 2, RRHL: Number of Participants With Best Clinical Response Post Completion of Each Line of Treatment

    Time frame: From post completion of frontline treatment until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Best clinical response as CR, PR, SD, or PD was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. SD was defined by failure to achieve CR, PR, or PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.

  58. Mean Duration of Best Response

    Time frame: From CR or PR until first documentation of relapse or disease progression or until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Duration of best response was defined as the time from when the criteria for response (CR or PR) were met to first documentation of relapse or disease progression, and was evaluated based on IWG criteria (Cheson et al 2007). CR was the disappearance of all evidence of disease. PR was the regression of measurable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir.

  59. Median Overall Survival (OS)

    Time frame: From initial diagnosis until the date of death (or date when the participant was alive) (Group 1); From first relapse after frontline therapy to death (Group 2) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Median OS was defined as the time from diagnosis of cHL to death(Group 1)/ time from first relapse after frontline therapy to death (Group 2), censored at date of most recent follow-up/contact.

  60. Group 1, cHL: Overall Survival Rate After Diagnosis at 1 and 5 Years

    Time frame: At 1 year and 5 years after diagnosis (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Percentage of participants who were alive at 1 and 5 years after diagnosis in cHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods.

  61. Group 2, RRHL: Overall Survival Rate at 1 and 5 Years

    Time frame: At 1 year and 5 years after relapse (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Percentage of participants who were alive at 1 and 5 years after diagnosis in RRHL participants are reported. 5 year overall survival data were reported only for participants who had >5 year observation periods.

  62. Group 1, cHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professionals Related to HL

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  63. Group 1, cHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  64. Group 1, cHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits.

  65. Group 1, cHL: Number of Participants Categorized Based on Episodes of RT Received, Type of Scan or Procedure, and Who Received Granulocyte-colony Stimulating Factor (G-CSF) or High-cost Medicines and Pegylated G-CSF Related to HL

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  66. Group 1, cHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

  67. Group 2, RRHL: Number of Participants Who Had Inpatient Hospital Admissions, Emergency Room Visits, and Outpatient Visits by Healthcare Professional Related to HL for Salvage Therapy and ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Each participant had more than one category presented for salvage therapy and ASCT.

  68. Group 2, RRHL: Number of Participants Categorized Based on Reasons for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Each participant had more than one category presented for salvage therapy and ASCT.

  69. Group 2, RRHL: Mean Overall Length of Stay and Length of Stay by Unit/Ward for Inpatient Hospital Admissions Related to HL for Salvage Therapy and ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Length of stay by unit or ward included general, high dependency/intermediate, intensive care unit, bone marrow transplant unit, and emergency visits. Each participant had more than one category presented for salvage therapy and ASCT.

  70. Group 2, RRHL: Number of Participants Categorized Based on Episodes of RT, Type of Scan or Procedure, and Who Received G-CSF or High-cost Medicines Related to HL for Salvage Therapy and ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

    Each participant had more than one category presented for salvage therapy and ASCT. Scan procedures included chest x-ray, magnetic resonance imaging, needle biopsy, bone scan, bone marrow aspiration, flow cytometry, and other scan procedures.

  71. Group 2, RRHL: Group 2, RRHL: Mean Number of Courses of Treatment With G-CSF/Pegylated G-CSF or Other High-cost Medicines Related to HL Treatment for Salvage Therapy and ASCT

    Time frame: From initial diagnosis until the date of death (or the date when the participant was last known to be alive) (observed retrospectively from 2010 until date of data collection [up to 9 years 10 months])

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

An International, Multi-centre, Non-interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients With Classical Hodgkin Lymphoma (B-HOLISTIC)

Acronym: B-HOLISTIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2017
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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