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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00199082
Other study ID # GMALL05
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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