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Chemotherapy

New Cancer Treatment for Non-Hodgkin's Lymphoma

Phase 2 & 3

Waitlist Available

Led By Raul Ribeiro, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

Histologic diagnosis other than a mature B-cell lymphoma as defined in the WHO classification.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after the last participant is enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment for children with B-cell NHL. The new treatment is based on the successful LMB-96 regimen. The trial features prospective biologic and late effect studies.

Who is the study for?

This trial is for children and young adults under 22 years old with a diagnosis of mature B-cell lymphoma, such as Burkitt lymphoma or diffuse large B-cell lymphoma. They must be previously untreated or have had minimal treatment. Those with hepatitis B can participate but won't receive rituximab; HIV-positive patients are excluded from the therapy part but can join biology studies.

What is being tested?

The study tests modified treatments based on the LMB-96 regimen for various types of mature B-cell lymphomas in children. It's a phase III trial focusing on improving outcomes by studying tumor biology and long-term effects of these therapies.

What are the potential side effects?

Potential side effects may include reactions to chemotherapy like nausea, hair loss, increased infection risk due to weakened immune system, and specific issues related to drugs used (COPAD, CYM etc.), which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of lymphoma (like Burkitt or large B-cell).

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I was diagnosed before turning 22 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma is not classified as a mature B-cell type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after the last participant is enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after the last participant is enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after the last participant is enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Catalog and estimate frequencies of copy number variations in childhood lymphomas

Gene differential profiling of Burkitt Lymphoma (BL) vs. non-BL

Genes

+2 more

Secondary study objectives

Complete response rate

Event-free survival

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group CExperimental Treatment1 Intervention

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

Group II: Group BExperimental Treatment1 Intervention

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.

Group III: Group AExperimental Treatment1 Intervention

Completely resected stage I or completely resected abdominal stage II lesions. Group A will include: COPAD x 2 cycles.

0 / 3Eligibility criteria met