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Modent B-celle lymfom og leukæmi undersøgelse III

6. november 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

128

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 21 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Group A

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

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

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

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

Andre navne:
  • filgrastim
  • VCR
  • Neupogen
  • Adriamycin
  • Neulasta®
  • cytoxan
  • prednison
Andet: 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.
Medicin: 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.

Andre navne:
  • filgrastim
  • Rituxan
  • Ara-C
  • Cytoxan
  • MTX
  • folinsyre
  • VCR
  • Adriamycin
  • Neulasta®
  • Elitek
  • prednison
Andet: 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
Medicin: 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.

Andre navne:
  • VP16
  • filgrastim
  • Rituxan
  • Ara-C
  • MTX
  • folinsyre
  • VCR
  • Adriamycin
  • Neulasta®
  • cytoxan
  • Elitek
  • prednison

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gene Differential Expression Profiling of Burkitt Lymphoma (BL) vs. Non-BL in the US and Other Selected Geographic Regions of the World
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

St. Jude Children's Research Hospital

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. september 2010

Primær færdiggørelse (Faktiske)

31. august 2023

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

8. januar 2010

Først indsendt, der opfyldte QC-kriterier

11. januar 2010

Først opslået (Anslået)

12. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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