Fact CheckerSign in

NCT01046825Active, not recruitingPhase 2/3

Mature B-Cell Lymphoma And Leukemia Study III

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
128 (actual)
First submitted
8 Jan 2010
Start date
9 Sept 2010
Primary completion date
31 Aug 2023
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT01046825

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 128
  • From 9 Sept 2010 to the primary completion date, 31 Aug 2023
  • 4 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants known to be HIV positive (for therapeutic part of protocol, HIV participants are eligible for biology studies).

Other

  • Participants from Collaborating Sites Participating in Therapeutic and Biological Objectives:
  • Participants who are pregnant or lactating.
  • Inability or unwillingness of research participant or legal guardian to consent.
    • Participants from Collaborating Sites Participating in Biological Objectives Only:
  • Inability or unwillingness of research participant or legal guardian to consent.
  • Histologic diagnosis other than a mature B-cell lymphoma as defined in the WHO classification.

Who the study is looking for

  • St. Jude participants and collaborating sites participating in therapeutic and biological objectives:
  • 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 previously untreated, (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation).
  • Participant must be \< 22 years of age at the time of diagnosis
  • 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.
  • 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
  • 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.
  • Informed consent must be obtained according to St. Jude guidelines before enrollment into study.
    • Participants from Collaborating Sites Participating in Biological Objectives Only:
  • 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.
  • 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.
  • 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.

Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Cancer Hospital
Coordinator of this site? Confirm its status
CairoEgyptUnknown status
National University Health System
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Rady Children's Hospital - San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.