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

Lymphoblastic Lymphoma Clinical Trial

Official title:

Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199082
• Other study ID #: GMALL05
• Status: Completed
• Phase: Phase 4
• Start date: July 2002
• Est. completion date: June 2010

Study information

• Verified date: August 2022
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Burkitt's Leukemia
• Burkitt's Lymphoma
• Large Cell Anaplastic Lymphoma
• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Mediastinal Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Adriamycin

• Cyclophosphamide

• Cytarabine

• Dexamethasone/Prednisolone

• VP16

• Ifosfamide

• Methotrexate

• G-CSF

• Rituximab

• Vincristine/Vindesine

Procedure:
• Irradiation (in specific conditions)

Locations

Country	Name	City	State
Germany	University Hospital, Medical Dept. II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Nicola Goekbuget

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hoelzer D, Walewski J, Döhner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Dührsen U, Hüttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate
Primary	Remission duration
Primary	Disease free survival
Primary	Overall survival
Secondary	Dose and time compliance
Secondary	Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
Secondary	Death under therapy and in complete remission (CR)
Secondary	Localisations of relapse