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

Phase 4

Completed

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

• Registration Number: NCT00199082
• Lead Sponsor: Nicola Goekbuget

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	VP16	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Dexamethasone/Prednisolone	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Vincristine/Vindesine	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Irradiation (in specific conditions)	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Adriamycin	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Cyclophosphamide	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Cytarabine	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Ifosfamide	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Methotrexate	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	G-CSF	This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Experimental	Rituximab	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 Measures

Name	Time	Method
Remission rate
Remission duration
Disease free survival
Overall survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital, Medical Dept. II; 🇩🇪 Frankfurt, Germany