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

Phase 4CompletedNCT00199082

Nicola Goekbuget650 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

650

Conditions

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Remission rate

Remission duration

Disease free survival

Overall survival

Secondary Outcomes

Dose and time compliance

Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)

Death under therapy and in complete remission (CR)

Localisations of relapse