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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Adriamycin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Dexamethasone/Prednisolone

Intervention Type DRUG

VP16

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

G-CSF

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Vincristine/Vindesine

Intervention Type DRUG

Irradiation (in specific conditions)

Intervention Type PROCEDURE

Interventions

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Adriamycin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Dexamethasone/Prednisolone

Intervention Type DRUG

VP16

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

G-CSF

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Vincristine/Vindesine

Intervention Type DRUG

Irradiation (in specific conditions)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No