German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Adult Acute Lymphocytic Leukemia Clinical Trial

Official title:

Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199069
• Other study ID #: GMALL09
• Status: Completed
• Phase: Phase 4
• Start date: April 1993
• Est. completion date: May 2001

Study information

• Verified date: March 2023
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: May 2001
• Est. primary completion date: January 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Acute Lymphocytic Leukemia

• Age 15 - 65 years

Exclusion Criteria:

• Serious secondary diseases which may compromise intensified chemotherapeutical treatment

• Serious psychiatric diseases, which may compromise compliance with therapy

• HIV-1 or HIV-2 Infection

• Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids

• Patients without central diagnosis who cannot be allocated to a risk group

Related Conditions & MeSH terms

• Adult Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Asparaginase

• Vincristine

• Daunorubicin, Adriamycin

• Cyclophosphamide

• Ifosfamide

• Cytarabine

• Mitoxantrone

• Methotrexate

• 6-Mercaptopurine

• 6-Thioguanine

• VM26

• Dexamethasone / Prednisolone

Procedure:
• CNS Irradiation

• Mediastinal Irradiation

• Stem Cell Transplantation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	Deutsche Krebshilfe e.V., Bonn (Germany)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission rate, disease free survival, overall survival
Secondary	death in induction, toxicity, time and dose compliance

External Links

•   European Leukemia Trial Registry