Mature B-Cell Lymphoma And Leukemia Study III

  • STATUS
    Recruiting
  • End date
    Aug 27, 2027
  • participants needed
    168
  • sponsor
    St. Jude Children's Research Hospital
Updated on 27 July 2022

Summary

This is a phase III clinical trial using risk-adapted therapy. Treatment outcomes for children with B-cell NHL are excellent. Further improvements in outcome will likely be achieved through more focused study of the biology of the tumors and prospective studies of the late effects of treatment. Toward this end, this study features a spectrum of prospective biologic and late effect studies performed in patients treated with a modified regimen derived from the very successful LMB-96 regimen.

Description

  1. This study will perform analysis of newly diagnosed mature B-cell lymphomas (e.g. Burkitt lymphoma/leukemia, DLBCL, and MLBCL) obtained from participants in different parts of the world.
  2. This study will describe the types and frequency of mutations in the ARF-HDM2-TP53 pathway, in B-cell lymphomas in the United States and that found in selected geographic regions of the world.
  3. This study will describe the expression of ARF-HDM2-TP53 and PUMA-associated pathways in B-cell lymphomas in the United States and that found in B-cell lymphomas of other selected geographic regions of the world.
  4. This study will describe the pattern and frequency of XLP gene mutations presenting with B-cell lymphomas in the United States and selected geographic regions.
  5. This study will describe the frequency of EBV-positive B-cell lymphomas in the United States and selected geographic regions of the world: and will describe the pattern of EBV protein and gene expression (e.g., EBNA 3) in EBV-positive lymphomas and the study will compare patterns of EBV protein and gene expression with clinical, laboratory and outcome data.

Secondary Objective:

To estimate the complete response rate, event-free survival, and overall survival rates in patients with Burkitt lymphoma (BL), Burkitt leukemia/B-cell acute leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL) treated with a stage-adapted regimen based on the St. Jude B-cell II protocol.

Details
Condition Mature B-Cell Lymphoma
Treatment COPAD, COP, COPD M3, CYM, COP, COPADM8, CYVE
Clinical Study IdentifierNCT01046825
SponsorSt. Jude Children's Research Hospital
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

St. Jude participants and collaborating sites participating in therapeutic and biological
objectives
Participant must have a histologic diagnosis of a mature B cell lymphoma (e.g
Burkitt lymphoma/leukemia, atypical Burkitt lymphoma, diffuse large B-cell lymphoma
mediastinal large B-cell lymphoma, mature B-cell lymphoma NOS) as defined in the WHO
classification
Participant must be < 22 years of age at the time of diagnosis
Participant must be previously untreated, (no more than 72 hours of steroids, one
intrathecal chemotherapy treatment, and/or emergency radiation)
enrollment
Hepatitis B immunization status (vaccination Yes or No)
For selected higher-risk CD20+ Group B and all CD20+ Group C participants receiving
HBsAg
Anti-HBs antibody
rituximab only (e.g., those with MLBLC, Stage III with LDH ≥ 2 times upper limit of
normal (ULN), and/or bone marrow/CNS involvement: All participants who will receive
rituximab must have hepatitis screening prior to enrollment. Participants whose
results indicate that they are carrier of hepatitis B can still be treated per Group B
or C but will NOT receive rituximab. This screening must be done for eligibility for
participants who will receive rituximab, BUT the results are not needed prior to
Participant must be < 22 years of age at the time of diagnosis
Anti-HBc antibody
All participants must have screening prior to enrollment; participants whose results
indicate that they are carrier of hepatitis B can still be treated per group B and C
but will NOT receive rituximab
HIV test has been obtained within 42 days. Participants who test positive for HIV
cannot be enrolled on therapeutic part of study, but are still eligible for biology
studies
Informed consent must be obtained according to St. Jude guidelines before enrollment
into study
Participants from Collaborating Sites Participating in Biological Objectives Only
Participant must have a histologic diagnosis of a mature B cell lymphoma (e.g
Burkitt lymphoma/leukemia, atypical Burkitt lymphoma, diffuse large B-cell lymphoma
mediastinal large B-cell lymphoma, mature B-cell lymphoma NOS) as defined in the WHO
classification
Participant must be previously untreated (no more than 72 hours of steroids, one
intrathecal chemotherapy treatment, and/or emergency radiation) at the time of the
diagnostic biopsy
Informed consent must be obtained by local PI or his/her designee according to
ICH/Good Clinical Practice and local guidelines before enrollment into study

Exclusion Criteria

Objectives
Participants who are pregnant or lactating
Inability or unwillingness of research participant or legal guardian to consent
Inability or unwillingness of research participant or legal guardian to consent
Participants from Collaborating Sites Participating in Therapeutic and Biological
Participants known to be HIV positive (for therapeutic part of protocol, HIV
participants are eligible for biology studies)
Participants from Collaborating Sites Participating in Biological Objectives Only
Histologic diagnosis other than a mature B-cell lymphoma as defined in the WHO
classification
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