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NCT Number: NCT01369784

Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma

The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Elda, Elda, Alicante, Spain

Loading trial locations.

About this study

The main aim of this study is to compare the prognostic value of R-IPI at diagnosis and relapse, relating it with the obtained response after second line

Who can participate

Healthy volunteers accepted: No

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

  • Age 18 > years old
  • Patients with refractory/relapsed diffuse large B-cell lymphoma after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab
  • Ability to understand and willingness to sign a written informed consent

Treatment and study plan

Primary outcomes

  1. R-IPI Index (Revised International Prognostic Index)

    Time frame: At diagnoses

    Data will be recorded from diagnosis to second line response, an expected average of 7 months

  2. R-IPI Index (Revised International Prognostic Index)

    Time frame: At the beginning of the 2nd line of treatment, an average of 2 years

    The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.

  3. Predictive Value of R-IPI at Diagnosis

    Time frame: At diagnosis

Secondary outcomes

  1. Bcl-2 Expression

    Time frame: At diagnosis

    immunohistochemical reaction of cells with Bcl-2 antibody

  2. Bcl-2 Expression

    Time frame: At the beginning of the 2nd line of treatment

    immunohistochemical reaction of cells with Bcl-2 antibody

  3. Bcl-6 Expression

    Time frame: At diagnosis

    immunohistochemical reaction of cells with Bcl-6 antibody

  4. Bcl-6 Expression

    Time frame: At the beginning of the second line of treatment

    immunohistochemical reaction of cells with Bcl-6 antibody

  5. p-53 Expression

    Time frame: At diagnosis

    immunohistochemical reaction of cells with p-53 antibody

  6. p53 Expression

    Time frame: At the beginning of the 2nd line of treatment

    immunohistochemical reaction of cells with p-53 antibody

  7. Multiple Myeloma Oncogene 1 (MUM-1) Expression

    Time frame: At diagnosis

    immunohistochemical reaction of cells with MUM-1 antibody

  8. MUM-1 Expression

    Time frame: At the beginning of the 2nd line of treatment

    immunohistochemical reaction of cells with MUM-1 antibody

  9. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status

    Time frame: At the beginning of the 2nd line of treatment

    ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus

  10. Ann Arbor Staging

    Time frame: At the beginning of the 2nd line of treatment

    Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition

  11. Response to First Line of Treatment

    Time frame: After first line treatment

    Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.

    Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.

  12. Response to Second Line of Treatment

    Time frame: After second line of treatment

    Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.

    Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.

  13. Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis

    Time frame: At diagnosis

    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

  14. Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis

    Time frame: At diagnosis

    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

  15. Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis

    Time frame: At diagnosis

    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

  16. Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis

    Time frame: At diagnosis

    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

Sponsors and collaborators

Lead sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Other

Registry information

Official study title

Observational, Post-authorization, Cross-sectional Study to Evaluate the Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma

Acronym: PRO-R-IPI

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2011
Registry last updated
Apr 18, 2016

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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