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

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00199056
• Collaborator: (none)
• Enrollment: 225
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Lymphocytic Leukemia	Drug: Dexamethasone / Prednisolone; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Vincristine / Vindesine; Drug: Daunorubicin; Drug: Asparaginase; Drug: G-CSF; Drug: Cytarabine; Drug: 6-Mercaptopurine; Drug: VP16; Drug: Adriamycin; Drug: Thioguanine; Drug: VM26; Drug: Idarubicin; Drug: Fludarabine; Drug: Ifosfamide; Procedure: CNS irradiation; Procedure: Mediastinal irradiation (if residual tumor); Procedure: stem cell transplantation	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)
• Study Start Date: Oct 1, 1999

Outcome Measures

Primary Outcome Measures

1. Remission rate,Remission duration,Disease free survival,Overall survival []

Secondary Outcome Measures

1. Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital, Medical Dept. II	Frankfurt		Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Study Chair: Dieter Hoelzer, MD,PhD, University Hospital Frankfurt, Medical Dept. II

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• European Leukemia Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00199056
• Other Study ID Numbers: GMALL10
• First Posted: Sep 20, 2005
• Last Update Posted: May 20, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: ALL; Treatment; De Novo; Adult
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Ifosfamide; Methotrexate; Fludarabine; Vincristine; Doxorubicin; Daunorubicin; Asparaginase; Mercaptopurine; Idarubicin; Thioguanine; Vindesine

Study Results

No Results Posted as of May 20, 2008