Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

Sponsor
Nicola Goekbuget
Study ID
NCT00199082
Phase
PHASE4
Status
Completed

Conditions

  • Burkitt's Leukemia
  • Burkitt's Lymphoma
  • Large Cell Anaplastic Lymphoma
  • Lymphoblastic Lymphoma
  • Mediastinal Neoplasms

Eligibility Criteria

Sex
ALL
Age
15 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adriamycin — DRUG
  • Cyclophosphamide — DRUG
  • Cytarabine — DRUG
  • Dexamethasone/Prednisolone — DRUG
  • VP16 — DRUG
  • Ifosfamide — DRUG
  • Methotrexate — DRUG
  • G-CSF — DRUG
  • Rituximab — DRUG
  • Vincristine/Vindesine — DRUG
  • Irradiation (in specific conditions) — PROCEDURE

Study Details

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Key Dates

Start date
Jul 31, 2002
Status verified
Aug 2022
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
650 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement

Primary Outcome Measure

Remission rate

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