Mature B-Cell Lymphoma And Leukemia Study III
Information source: St. Jude Children's Research Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mature B-Cell Lymphoma
Intervention: COPAD (Drug); COP, COPD M3, CYM (Drug); COP, COPADM8, CYVE (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: St. Jude Children's Research Hospital Official(s) and/or principal investigator(s): John T Sandlund, MD, Principal Investigator, Affiliation: St. Jude Children's Research Hospital
Overall contact: John T Sandlund, MD, Phone: 1-866-278-5833, Email: referralInfo@stjude.org
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.
Clinical Details
Official title: Mature B-Cell Lymphoma And Leukemia Study III
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Gene differential profiling of Burkitts Lymphoma (BL) vs. non-BLCatalog and estimate frequencies of copy number variations in childhood lymphomas Integrated analysis of CNVs and gene expressions Pattern and frequency of XLP gene mutations presenting with B-cell lymphomas in the United States and selected geographic regions Pattern of EBV protein expression (e.g., EBNA 3) in EBV-positive lymphomas and to compare patterns of EBV protein expression with clinical, laboratory and outcome data
Secondary outcome: Complete response rateEvent-free survival Overall Survival Percentage of participants who complete therapy with the use of rituximab Number of possible rituximab-related toxicities
Detailed description:
1. This study will perform transcriptional profiling and genome-wide analysis of DNA copy
number abnormalities and loss-of-heterozygosity using DNA microarrays in children with
newly diagnosed diffuse large B-cell lymphomas (DLBCL) and small non-cleaved lymphomas
from different parts of the world.
2. This study will describe the types and frequency of mutations in the ARF-HDM2-TP53
pathway, in "non-endemic" B-cell lymphomas (United States) and those 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 (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.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
St. Jude Participants:
1. 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.
2. Participant must be previously untreated, (no more than 72 hours of steroids and/or
emergency radiation)
3. Participant must be < 22 years of age at the time of diagnosis
4. For Group B participants with mediastinal large B cell lymphoma (MLBCL) disease only
(receiving rituximab) - All participants with MLBCL assigned to Group B 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 but will NOT receive
rituximab. This screening must be done for eligibility BUT the results are not needed
prior to enrollment:
- Hepatitis B immunization status (vaccination Yes or No)
- HBsAg
- Anti-HBs antibody
- 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 but will NOT receive rituximab.
5. 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.
6. Informed consent must be obtained according to St. Jude guidelines before enrollment
into study
Participants from Collaborating Sites Participating in Biological Objectives Only:
1. 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
2. Participant must be < 22 years of age at the time of diagnosis
3. 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:
Participants from Collaborating Sites Participating in Therapeutic and Biological
Objectives:
1. Participants with prior therapy (except steroids or RT)
2. Participants known to be HIV positive (for therapeutic part of protocol, HIV
participants are eligible for biology studies).
3. Participants who are pregnant or lactating
4. Inability or unwillingness of research participant or legal guardian to consent
5. Participants who received emergent steroids and/or radiation prior to biopsy may be
included in therapeutic part of study, but will be excluded from biology studies.
Participants from Collaborating Sites Participating in Biological Objectives Only:
1. Inability or unwillingness of research participant or legal guardian to consent
2. Histologic diagnosis other than a mature B-cell lymphoma as defined in the WHO
classification
3. Participants who received emergent steroids and/or radiation prior to biopsy
Locations and Contacts
John T Sandlund, MD, Phone: 1-866-278-5833, Email: referralInfo@stjude.org
Children's Cancer Hospital, Cairo 11787, Egypt; Recruiting Hany Abdel Rahman, MD Hany Abdel Rahman, MD, Principal Investigator
National University Health System, Singapore 119228, Singapore; Recruiting Allen Yeoh, MD, Email: allen_yeoh@nuhs.edu.sg Allen Yeoh, MD, Principal Investigator
Rady Children's Hospital San Diego, San Diego, California 92123, United States; Recruiting Deborah Schiff, MD, Phone: 858-966-5811, Email: dschiff@rchsd.org Deborah Schiff, MD, Principal Investigator
St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States; Recruiting John T Sandlund, MD, Phone: 866-278-5833, Email: referralinfo@stjude.org John T Sandlund, MD, Principal Investigator
Additional Information
St. Jude Children's Research Hospital Clinical Trials Open at St. Jude
Starting date: January 2009
Last updated: August 17, 2015
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