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Moget B-cells lymfom och leukemi studie III

6 november 2026 uppdaterad av: St. Jude Children's Research Hospital

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

  1. This study will perform analysis of newly diagnosed mature B-cell lymphomas (e.g. Burkitt lymphoma/leukemia, DLBCL, and MLBCL) obtained from participants in different parts of the world.
  2. This study will describe the types and frequency of mutations in the ARF-HDM2-TP53 pathway, in B-cell lymphomas in the United States and that 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 in the 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.

Exploratory Aims:

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

128

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Egypten
      • Cairo, Egypten, 11787
        • Children's Cancer Hospital
  • Förenta staterna
    • California
      • San Diego, California, Förenta staterna, 92123
        • Rady Children's Hospital San Diego
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38105
        • St. Jude Children's Research Hospital
  • Singapore
      • Singapore, Singapore, 119228
        • National University Health System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 21 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Group A

Completely resected stage I or completely resected abdominal stage II lesions.

Group A will include: COPAD x 2 cycles.
Läkemedel: COPAD

Vincristine Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF

In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.

Andra namn:
  • filgrastim
  • Videobandspelare
  • Neupogen
  • Adriamycin
  • Neulasta®
  • cytoxan
  • prednison
Övrig: Group B

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.
Läkemedel: COP, COPD M3, CYM

GROUP B Treatment Details Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3 Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, IT medications, G-CSF, Rituximab Consolidation (2 cycles): Methotrexate, Leucovorin, Cytarabine, IT medications, G-CSF, Rituximab

In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.

Andra namn:
  • filgrastim
  • Rituxan
  • Ara-C
  • Cytoxan
  • MTX
  • folinsyra
  • Videobandspelare
  • Adriamycin
  • Neulasta®
  • Elitek
  • prednison
Övrig: Group C

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
Läkemedel: COP, COPADM8, CYVE

Treatment: Intravenous fluids should be given at a rate of 3000 mL/m2/day. Use of rasburicase may preclude the need for HCO3.

COP Pre-Phase: Cyclophosphamide, Vincristine, Prednis(ol)one, IT medications, Leucovorin.

COPADM8 Induction (2 cycles): Vincristine, Prednis(ol)one, Methotrexate, Leucovorin, Cyclophosphamide, Doxorubicin, Rituximab, IT medications, G-CSF CYVE Consolidation (2 cycles): Cytarabine, High-Dose Ara-C, Etoposide, Rituximab, G-CSF.

Maintenance No.1: Vincristine, Prednis(ol)one, Cyclophosphamide, Methotrexate, Leucovorin, Doxorubicin, IT medications, G-CSF.

Maintenance No.2: Cytarabine, Etoposide, G-CSF, IT Medications. Maintenance No.3: Vincristine, Prednis(ol)one, Cyclophosphamide, Doxorubicin, G-CSF, IT Medications.

Maintenance No. 4: Cytarabine, Etoposide, G-CSF, IT Medications.

In the event the patient cannot receive G-CSF, Pegfilgrastim can be substituted.

Andra namn:
  • VP16
  • filgrastim
  • Rituxan
  • Ara-C
  • MTX
  • folinsyra
  • Videobandspelare
  • Adriamycin
  • Neulasta®
  • cytoxan
  • Elitek
  • prednison

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Gene Differential Expression Profiling of Burkitt Lymphoma (BL) vs. Non-BL in the US and Other Selected Geographic Regions of the World
Tidsram: 1 year after the participant is enrolled

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 participant is enrolled
Catalog and Estimate Frequencies of Copy Number Variations in Childhood Lymphomas
Tidsram: 1 year after the participant is enrolled

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. The CNVs are derived from Affymetrix SNP arrays.
1 year after the participant is enrolled
Integrated Analysis of CNVs and Gene Expressions in the US and Other Selected Geographic Regions of the World
Tidsram: 1 year after the participant is enrolled

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. Gene expressions are measured by Affymetrix U133A arrays and CNVs are derived from Affymetrix SNP arrays.
1 year after the participant is enrolled
Pattern and Frequency of XLP Gene Mutations Presenting With B-cell Lymphomas in the United States and Selected Geographic Regions
Tidsram: 1 year after the participant enrollment

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 participant enrollment
Frequency of EBV Protein Expression (e.g., EBNA 3) in EBV-positive Lymphomas
Tidsram: 1 year after the participant is enrolled

Frequency of EBV-positive BL will be calculated for each geographical region.
1 year after the participant is enrolled

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: Up to 5 years after completion of therapy

Overall survival (OS) will be estimated among eligible patients treated at SJCRH by the Kaplan-Meier estimator.
Up to 5 years after completion of therapy
Event-free Survival
Tidsram: Up to 5 years after completion of therapy

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).
Up to 5 years after completion of therapy
Complete Response Rate
Tidsram: Up to 5 years after completion of therapy

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
Up to 5 years after completion of therapy

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

St. Jude Children's Research Hospital

Utredare

  • Huvudutredare: Raul Ribeiro, MD, St. Jude Children's Research Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 september 2010

Primärt slutförande (Faktisk)

31 augusti 2023

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

8 januari 2010

Först inskickad som uppfyllde QC-kriterierna

11 januari 2010

Första postat (Beräknad)

12 januari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SJBC3
  • NCI-2011-01251 (Registeridentifierare: NCI Clinical Trial Registration Program)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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