Mature B-Cell Lymphoma Clinical Trial
Official title:
Mature B-Cell Lymphoma And Leukemia Study III
| Verified date | April 2024 |
| Source | St. Jude Children's Research Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 128 |
| Est. completion date | August 2027 |
| Est. primary completion date | August 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 21 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Children's Cancer Hospital | Cairo | |
| Singapore | National University Health System | Singapore | |
| United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
| United States | Rady Children's Hospital San Diego | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| St. Jude Children's Research Hospital |
United States, Egypt, Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gene differential profiling of Burkitt Lymphoma (BL) vs. non-BL | 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. | 1 year after the last participant is enrolled | |
| Primary | Catalog and estimate frequencies of copy number variations in childhood lymphomas | 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. | 1 year after the last participant is enrolled | |
| Primary | Integrated analysis of CNVs and gene expressions | 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. | 1 year after the last participant is enrolled | |
| Primary | Pattern and frequency of XLP gene mutations presenting with B-cell lymphomas in the United States and selected geographic regions | 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. | 1 year after the last participant enrollment | |
| Primary | 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 | Point estimates and 95% CIs of the frequency of EBV-positive BL will be calculated for each geographical region. EBV protein expression will be described by summary statistics.
Relationship of EBV protein expression with clinical, laboratory, and outcome features will be explored using appropriate statistical methods such as general linear models. |
1 year after the last participant is enrolled | |
| Secondary | Complete response rate | 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 | 5 years after completion of therapy | |
| Secondary | Event-free survival | 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). | 5 years after completion of therapy | |
| Secondary | Overall Survival | Overall survival (OS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator. | 5 years after completion of therapy |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04088422 -
Cell Free DNA in Mature B-cell Lymphoma
|