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Mature B-Cell Lymphoma And Leukemia Study III


Phase 3
N/A
21 Years
Open (Enrolling)
Both
Mature B-Cell Lymphoma

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Trial Information

Mature B-Cell Lymphoma And Leukemia Study III


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.


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) - Hepatitis screening has been obtained. 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To perform transcriptional profiling and genome-wide analysis of DNA copy number abnormalities and loss-of-heterozygosity using DNA microarrays in children with newly diagnosed mature B cell lymphomas

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

John T Sandlund, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

SJBC3

NCT ID:

NCT01046825

Start Date:

January 2010

Completion Date:

June 2016

Related Keywords:

  • Mature B-Cell Lymphoma
  • Lymphoma
  • Leukemia
  • Non-Hodgkin's Lymphoma
  • Leukemia
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Rady Children's Hospital San DiegoSan Diego, California  92123