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Mature B-Cell Lymphoma And Leukemia Study III

StatusActive, Not Recruiting
PhasePhase 2/3
Started2010-09-09
View on ClinicalTrials.gov ↗

Amendment history

2026-05-15
minor
3 amendments v30-v32
3 re-verifications since 2025-11-10, no change to tracked fields
2025-05-28
minor
Study Status, Study Description, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v29
Results first postednot stated→2025-05-30
Secondary endpoints-59 characters
Complete response rate Event-free survival Overall Survival
Primary endpoints5 entries, revised
Catalog and estimateEstimate frequenciesFrequencies of copyCopy numberNumber variationsVariations in childhoodChildhood lymphomasLymphomas Gene differential profiling of Burkitt Lymphoma (BL) vs. non-BL Integrated analysis of CNVs and gene expressions Pattern and frequency of XLP gene mutations presenting with B-cell lymphomas in the United States and selected geographic regions PatternFrequency of EBV proteinProtein expressionExpression (e.g., EBNA 3) in EBV-positive lymphomasLymphomas Gene Differential Expression Profiling of Burkitt Lymphoma (BL) vs. Non-BL in the US and toOther compareSele [...] [...]
Study description-3 characters
[...] gene expression with clinical, laboratory and outcome data. SecondaryExploratory ObjectiveAims: To estimate the complete response rate, event-free surviva [...]
2024-04-10
minor
Study Status, Outcome Measures v28
Secondary endpoints5 to 3 entries
Percentage of participants who complete therapy with the use of rituximab Number of possible rituximab-related toxicities
2024-03-22
minor
Study Status v27
Re-verified, no change to tracked fields
2023-09-11
minor
Study Status v26
Primary completion dateestimated 2023-08→confirmed 2023-08-31
Show 25 earlier versions
2023-03-31
minor
Study Status v25
Re-verified, no change to tracked fields
2022-09-23
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v24
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2023-11→2023-08
Enrollment targetestimated 168→confirmed 128
Study sitesdetails revised at 4 of 4 sites
2022-08-09
minor
Study Status, Arms and Interventions v23
Re-verified, no change to tracked fields
2022-07-19
minor
Study Status v22
Primary completion date2022-10-31→2023-11
Completion date2027-08-31→2027-08
2022-01-19
minor
2 amendments v20-v21
2 re-verifications since 2021-02-12, no change to tracked fields
2020-06-16
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v19
Completion date2022-10-31→2027-08-31
Eligibility criteria+206 characters
[...] er limit of normal (ULN), and/or bone marrow/CNS involvement. : All participants who will receive rituximab must have hepatitis screening prior to en [...] ation 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 [...]
Primary endpoints5 entries, revised
Gene differential profiling of BurkittsBurkitt Lymphoma (BL) vs. non-BL
Study sitescontacts updated at 1 of 4 sites
2020-04-07
minor
Study Status, Eligibility v18
Eligibility criteria+123 characters
[...] rathecal 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 MLB [...] 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: Hepatit [...] ccording to St. Jude guidelines before enrollment into study. Participants from Collaborating Sites Participat [...] [...]
2019-07-17
minor
Study Status, Study Design, Contacts/Locations v17
Enrollment target122→168
Study sitesdetails revised at 1 of 4 sites
2018-07-06
minor
Study Status, Arms and Interventions v16
Re-verified, no change to tracked fields
2017-05-19
minor
Study Status, Study Description, Eligibility v15
Eligibility criteria-156 characters
Inclusion Criteria: St. Jude Participantsparticipants and collaborating sites participating in therapeutic and biological objectives: Participant must have a histologic diagnosis of a mature B [...] 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 Group B participants withreceiving mediastinal large B cell lymphoma (MLBCL) diseaserituximab only (receivinge.g., rituximabthose with MLBLC, Stage III with LDH ≥ 2 times upper limit of norm [...] [...]
Study description-114 characters
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 largemature B-cell lymphomas (e.g. Burkitt lymphoma/leukemia, DLBCL), and smallMLBCL) non-cleaved lymphomasobtained from participants in different parts of the world. This study will describe the [...] and frequency of mutations in the ARF-HDM2-TP53 pathway, in "non-endemic" B-cell lymphomas (in the United States) and thosethat found in selected geographic regions of the world. This stu [...] -HDM2-TP53 and PUMA [...]
2017-03-30
minor
Study Status, Oversight v14
Primary completion date2022-10→2022-10-31
Completion date2022-10→2022-10-31
Start date2009-01→2010-09-09
2016-08-16
minor
Study Status v13
Re-verified, no change to tracked fields
2016-02-11
minor
Study Identification, Study Status, Study Design v12
Enrollment target60→122
2015-08-17
minor
Study Identification, Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 4 sites
2015-02-26
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v10
Study sites2→4
Collaborators-38 characters
Children's Cancer Hospital Egypt 57357
2014-11-14
minor
Study Status, Study Design, Outcome Measures v9
PhasePhase 3→Phase 2/3
Primary completion date2016-06→2022-10
Completion date2016-06→2022-10
Start date2010-01→2009-01
Secondary endpoints1 to 5 entries
Complete response rate, event Event-free survival Overall andSurvival Percentage overallof survivalparticipants who complete therapy with the use of rituximab Number of possible rituximab-related toxicities
Primary endpoints5 entries, revised
ToCatalog describeand theestimate expressionfrequencies of ARFcopy number variations in childhood lymphomas Gene differential profiling of Burkitts Lymphoma (BL) vs. non-HDM2-TP53BL Integrated analysis of CNVs and PUMA-associatedgene pathways in B-cell lymphomas in the United States and that found in B-cell lymphomas of other selected geographic regions of the worldexpressions To describe the patternPattern and frequency of XLP gene mutations presenting with B-cell [...] mphomas in the United States and selected geographic regions. To describe the patternPattern of EBV protein expression (e.g., EBNA [...] [...]
2014-09-23
minor
Study Status, Sponsor/Collaborators, Arms and Interventions, References v8
Collaborators+38 characters
Children's Cancer Hospital Egypt 57357
2014-02-06
minor
Study Status v7
Re-verified, no change to tracked fields
2013-07-16
minor
Study Status, Eligibility v6
Eligibility criteria+198 characters
[...] cell lymphoma (MLBCL) disease only (receiving rituximab) - HepatitisAll participants with MLBCL assigned to Group B must have hepatitis screening hasprior beento obtainedenrollment. Participants whose results indicate that they are carrier of hepatitis B can still be treated per Group B but will NOT receive rituximab. This screening must be done for eligibility BUT the results [...]
2012-12-11
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Eligibility criteria-28 characters
[...] steroids and/or emergency radiation) Participant must be < 2122 years of age at the time of diagnosis For Group B participa [...] as defined in the WHO classification Participant must be < or = to 2122 years of age at the time of diagnosis Informed consent must [...] ives: Participants with prior therapy (except steroids or RT as described in 3.1.1) Participants known to be HIV positive (for therapeutic par [...]
Secondary endpoints1 entry, revised
ThisComplete studyresponse willrate, includeevent-free the study of acutesurvival and lateoverall effects of this treatment on the central nervous system, bone mineral density, fertility, and cardiac system.survival
Primary endpoints6 to 5 entries
To establish a tumor bank of mature B-cell lymphoma samples for future molecular studies aimed to clarify the role of c-MYC oncogene and its associated pathways,and other pathways found to harbor genetic alterations from the genomic profiling studies
Study description-69 characters
[...] and those found in selected geographic regions of the world (Brazil, Chile, Guatemala, Honduras, El-Salvador, Singapore and others). This study will describe the expression of ARF-HDM2-TP53 and PUMA-associated pathways in non-endemic B-cell lymphomas (United States) and that found in B-cell lymphomas of other selected geographic regions of the world (see above). This study will describe the pattern and frequency of XLP gene mutations in boys presenting with B-cell lymphomas in the United States and s [...] gene expression with clinical, laboratory and outcome data. ThisSecondary studyObjective: To w [...] [...]
Study sitesdetails revised at 1 of 2 sites
2012-04-18
minor
Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Eligibility, Contacts/Locations, References v4
PhasePhase 2/3→Phase 3
Primary completion date2014-06→2016-06
Completion date2014-06→2016-06
Eligibility criteria+393 characters
[...] tinal large B cell lymphoma (MLBCL) disease only (receiving rituxumabrituximab) - Hepatitis screening has been obtained. This screening mu [...] ination Yes or No) HBsAg Anti-HBs antibody Anti-HBc antibody. All participants must have screening prior to enrollment. Pa [...] till be treated per Group B 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 Non-Parti [...] [...]
Study description+19 characters
[...] 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. This [...]
Study sitescontacts updated at 1 of 2 sites
2011-07-06
minor
2 amendments v2-v3
2 re-verifications since 2011-01-31, no change to tracked fields
2010-07-14
minor
Study Status, Eligibility, Contacts/Locations v1
Study sites1→2
Eligibility criteria+86 characters
[...] as described in 3.1.1) Participants known to be HIV positive(for therapeutic part of protocol, HIV participants are eligible for biology studies). Participants who are pregnant or lactating Inability or unw [...]
2010-01-11
minor
Original filing
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.
Trial Details
NCT Number NCT01046825
Lead Sponsor St. Jude Children's Research Hospital
Conditions Mature B-Cell Lymphoma
Enrollment 128 participants
Start Date 2010-09-09
Primary Completion 2023-08-31 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-02