Title

Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    650
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.
Study Started
Jul 31
2002
Primary Completion
Jun 30
2010
Study Completion
Jun 30
2010
Last Update
Aug 19
2022

Drug Adriamycin

Drug Cyclophosphamide

Drug Cytarabine

Drug Dexamethasone/Prednisolone

Drug VP16

Drug Ifosfamide

Drug Methotrexate

Drug G-CSF

Drug Rituximab

Drug Vincristine/Vindesine

Procedure Irradiation (in specific conditions)

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

Criteria

Inclusion Criteria:

Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
Age > 15 years
Written informed consent

Exclusion Criteria:

Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
HIV infection
Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
Known severe allergy to foreign proteins
Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
Pregnancy or nursing
Participation in other studies that interfere with study therapy
No Results Posted