German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Adult Acute Lymphocytic Leukemia Clinical Trial

Official title:

Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199056
• Other study ID #: GMALL10
• Status: Completed
• Phase: Phase 4
• Start date: October 1999
• Est. completion date: December 2005

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 an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2005
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T)
• Age 15-65 yrs (*55-65 years if biologically younger according to general condition)

Exclusion Criteria:

• Severe comorbidity
• Cytostatic pre-treatment
• Pregnancy
• Missing written informed consent

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexamethasone / Prednisolone

• Cyclophosphamide

• Methotrexate

• Vincristine / Vindesine

• Daunorubicin

• Asparaginase

• G-CSF

• Cytarabine

• 6-Mercaptopurine

• VP16

• Adriamycin

• Thioguanine

• VM26

• Idarubicin

• Fludarabine

• Ifosfamide

Procedure:
• CNS irradiation

• Mediastinal irradiation (if residual tumor)

• stem cell transplantation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate,Remission duration,Disease free survival,Overall survival
Secondary	Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD

External Links

•   European Leukemia Trial Registry