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Completed

NCT Number: NCT01325194

CHemoImmunotherapy With Early Central Nervous System (CNS) Prophylaxis

The purpose is to test whether early central nervous system (CNS) prophylaxis given at the beginning of therapy for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could reduce the risk of CNS relapses. Early CNS prophylaxis with two courses high dose methotrexate (HD-MTX) in combination with rituximab-cyclophosphamide-doxorubicin-vincristine-prednison (R-CHOP) is followed by four courses of R-CHOP14 and etoposide (E) and one course of HD-Ara-C. In addition the patients will receive three courses of liposomal cytarabine intrathecally. The results will be compared to a recent Nordic CRY-04 study. Shifting of CNS prophylaxis to the beginning of the therapy offers a potential to overcome the subclinical disease and thus reduce the risk of early clinical CNS recurrence. As flow cytometry (FCM) can improve the sensitivity for detecting occult leptomeningeal disease over cytology , FCM from cerebrospinal fluid will be incorporated into the staging procedures.

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Key information

Conditions

Primary Disease

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Hematology, Århus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 - < 65 years. Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) based on WHO 2008 Lymphoma Classification
  • Follicular lymphomas (FLs) grade 3b is allowed

Patients in at least stage II with age adjusted international prognostic score (IPI score) of 2 or 3:

  • Stage III /IV and elevated LDH
  • Stage III/IV and WHO performance status 2 - 3
  • Stage II and elevated LDH and WHO performance status 2 - 3 And/or patients with
  • More than one extranodal site
  • Testicular lymphoma, stage IIE and higher
  • Paranasal sinus and orbital lymphoma with destruction of bone
  • Large cell infiltration of the bone marrow

Exclusion criteria

  • Severe cardiac disease: cardiac function grade 3-4
  • Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
  • Pregnancy/lactation
  • Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment
  • Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons
  • Known HIV positivity
  • Uncontrolled infectious disease, including meningeal infection
  • Active cancer except basal cell carcinoma and cervical carcinoma in situ during the last five years
  • Earlier treatment containing anthracyclins
  • Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
  • CNS disease as diagnosed by MRI or cerebrospinal fluid (CSF) cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed
  • Pleural or peritoneal fluid that cannot be drained safely
  • Hypersensitivity to the active substance or any of the other ingredients
  • Patients participating in other clinical studies, unless followed for survival

Treatment and study plan

liposomal cytarabine

Drug

50 mg intrathecally three times

Other names: Depocyte

Primary outcomes

  1. Time to treatment failure

    Time frame: 3 and 5 years

Secondary outcomes

  1. Maximal hematological, gastrointestinal, neuronal and other toxicities

    Time frame: Treatment period (5 years)

  2. Clinical response rate

    Time frame: Treatment period (5 years)

  3. Incidence of central nervous system(CNS) relapse in cerebrospinal fluid (CSF )cytology neg/flow cytometry positive cases

    Time frame: 3 and 5 years

  4. Incidence of CNS relapse in a subgroup of patients with more than one extranodal site and elevated lactate dehydrogenase (LDH)

    Time frame: 3 and 5 years

  5. Progression free survival

    Time frame: 3 and 5 years

  6. Overall survival

    Time frame: 3 and 5 years

  7. Molecular predictors

    Time frame: 3 years

  8. CNS relapse rate

    Time frame: 1,5 years

Sponsors and collaborators

Lead sponsor

Nordic Lymphoma Group

Network

Collaborators

  • Amgen
  • Mundipharma Pte Ltd.

Registry information

Official study title

Dose Densified Chemoimmunotherapy With Early CNS Prophylaxis in Patients Less Than 65 Years With High Risk (aaIPI≥ 2) Diffuse Large B-Cell Lymphoma

Acronym: CHIC

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Mar 29, 2011
Registry last updated
Mar 3, 2020

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

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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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