Mature B-Cell Lymphoma And Leukemia Study III
Mature B-Cell Lymphoma
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2 / Phase 3
- Age range
- Not specified - 21 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 128 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Exploratory Aims:
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
St. Jude participants and collaborating sites participating in therapeutic and biological objectives:
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, one intrathecal chemotherapy treatment, and/or emergency radiation).
3. Participant must be \< 22 years of age at the time of diagnosis
4. For selected higher-risk CD20+ Group B and all CD20+ Group C participants receiving 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 enrollment:
* Hepatitis B immunization status (vaccination Yes or No)
* HBsAg
* Anti-HBs antibody
* Anti-HBc antibody.
5. 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
6. 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.
7. 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. 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.
4. 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 known to be HIV positive (for therapeutic part of protocol, HIV participants are eligible for biology studies).
2. Participants who are pregnant or lactating.
3. Inability or unwillingness of research participant or legal guardian to consent.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Group A
Completely resected stage I or completely resected abdominal stage II lesions.
Group A will include: COPAD x 2 cycles.
Drug: COPAD
Group B
All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV)
Group B will include the intervention COP, COPD M3, CYM as follows:
Pre-Phase: COP
Induction: COPAD M3 x 2 cycles
Consolidation: CYM x 2 cycles.
Drug: COP, COPD M3, CYM
Group C
Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies:
1. Any L3 blasts in CSF
2. Cranial nerve palsy (if not explained by extracranial tumor)
3. Clinical spinal cord compression
4. Isolated intracerebral mass
5. Parameningeal extension: cranial and/or spinal
Group C will include the intervention COP, COPADM8, CYVE as follows:
Pre-Phase: COP
Induction: COPADM8 cycle 1
Induction: COPADM8 Cycle 2
Consolidation: CYVE x 2 cycles
and Maintenance
Drug: COP, COPADM8, CYVE
COPAD DRUG
Vincristine Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF
In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.
COP, COPD M3, CYM DRUG
GROUP B Treatment Details Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3 Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, IT medications, G-CSF, Rituximab Consolidation (2 cycles): Methotrexate, Leucovorin, Cytarabine, IT medications, G-CSF, Rituximab
In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.
COP, COPADM8, CYVE DRUG
Treatment: Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3.
COP Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications, Leucovorin.
COPADM8 Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, Rituximab, IT medications, G-CSF CYVE Consolidation (2 cycles): Cytarabine, High-Dose Ara-C, Etoposide, Rituximab, G-CSF.
Maintenance No.1: Vincristine, Prednis(ol)one, Cyclophosphamide, Methotrexate, Leucovorin, Doxorubicin, IT medications, G-CSF.
Maintenance No.2: Cytarabine, Etoposide, G-CSF, IT Medications. Maintenance No.3: Vincristine, Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF, IT Medications.
Maintenance No. 4: Cytarabine, Etoposide, G-CSF, IT Medications.
In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Gene Differential Expression Profiling of Burkitt Lymphoma (BL) vs. Non-BL in the US and Other Selected Geographic Regions of the World
Time frame: 1 year after the participant is enrolled
Gene expression levels in BL vs. non-BL will be analyzed through approximately 22,000 probesets on the Affymetrix U133A GeneChip by using two-factor analysis of variance model for each gene.
Catalog and Estimate Frequencies of Copy Number Variations in Childhood Lymphomas
Time frame: 1 year after the participant is enrolled
The prevalence of CNVs between different subtypes of childhood lymphomas and geographic regions will be reported and compared with exact chi-square or Fisher's test. The CNVs are derived from Affymetrix SNP arrays.
Integrated Analysis of CNVs and Gene Expressions in the US and Other Selected Geographic Regions of the World
Time frame: 1 year after the participant is enrolled
The association between the identified CNVs and gene expressions in the study cohort will be examined by using general linear models, and multiple tests will be considered. Gene expressions are measured by Affymetrix U133A arrays and CNVs are derived from Affymetrix SNP arrays.
Pattern and Frequency of XLP Gene Mutations Presenting With B-cell Lymphomas in the United States and Selected Geographic Regions
Time frame: 1 year after the participant enrollment
Frequency of XLP mutation among boys will be calculated in each geographical region as well as in all regions pooled. The frequency is reported here as the number of boys with XLP gene mutations found in B-cell lymphomas boys.
Frequency of EBV Protein Expression (e.g., EBNA 3) in EBV-positive Lymphomas
Time frame: 1 year after the participant is enrolled
Frequency of EBV-positive BL will be calculated for each geographical region.
Other measures
Overall Survival
Time frame: Up to 5 years after completion of therapy
Overall survival (OS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator.
Event-free Survival
Time frame: Up to 5 years after completion of therapy
Event-free survival (EFS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. The events will include: (1) death while in continuous CR, (2) relapse, (3) secondary malignancy, and (4) failure to achieve complete response (CR).
Complete Response Rate
Time frame: Up to 5 years after completion of therapy
Complete response rate will be estimated with exact 95% CI based on the binomial distribution, and it will be reported as the percentage of patients who reached complete remission among eligible patients treated at SJCRH
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
Rady Children's Hospital San DiegoSan Diego, California, United StatesStatus unknown
St. Jude Children's Research HospitalMemphis, Tennessee, United StatesStatus unknown
Children's Cancer HospitalCairo, EgyptStatus unknown
National University Health SystemSingapore, SingaporeStatus unknown
Study team and timeline
- Lead sponsor
- St. Jude Children's Research Hospital
- Study start
- Sep 9, 2010 Actual
- Primary completion
- Aug 31, 2023 Actual
- Study completion
- 2027-08 Estimated
- First posted
- Jan 12, 2010 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Mature B-Cell Lymphoma And Leukemia Study III
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026