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

Nicola Goekbuget

Status and phase: Completed; Phase 4

Conditions: Burkitt's Leukemia; Large Cell Anaplastic Lymphoma; Lymphoblastic Lymphoma; Mediastinal Neoplasms; Burkitt's Lymphoma

Treatments: Drug: Rituximab; Drug: VP16; Drug: Vincristine/Vindesine; Drug: Cytarabine; Drug: Adriamycin; Drug: Ifosfamide; Drug: Methotrexate; Procedure: Irradiation (in specific conditions); Drug: Cyclophosphamide; Drug: Dexamethasone/Prednisolone; Drug: G-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT00199082

GMALL05

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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650 participants in 1 patient group

Experimental

Experimental group

Description:

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

Treatment:

Drug: Cytarabine

Drug: Cyclophosphamide

Drug: Adriamycin

Drug: Rituximab

Drug: Vincristine/Vindesine

Drug: Methotrexate

Drug: Dexamethasone/Prednisolone

Drug: VP16

Drug: G-CSF

Procedure: Irradiation (in specific conditions)

Drug: Ifosfamide