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NCT01497002 Clinical Trial

Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

Acute Myeloid Leukaemia Clinical Trial

— AML2004  

Official title:
Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01497002
Other study ID # OSHO#069
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2005
Est. completion date July 18, 2018

Study information
Verified date September 2022
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

Description:

Measuring EFS depending on induction therapy

Recruitment information / eligibility
Status Completed
Enrollment 1222
Est. completion date July 18, 2018
Est. primary completion date July 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification - written informed consent Exclusion Criteria: - pretreatment of leukemia - no informed consent - simultaneous inclusion in other studies - mental disability - contraindication for intensive chemotherapy - AML FAB M3 - contraindication for allogeneic stem cell transplantation - restriction of following organ functions: - creatinine-clearance < 50 ml/min - cardiac ejection fraction < 40 % - severe pulmonary restriction - bilirubin > 2x ULN; SGOT and SGPT > 4x ULN - uncontrolled hypertension - severe uncontrolled metabolism disturbance - Karnofsky-performance-score < 70% - hepatitis C - other malignancy - age of unrelated donor >70 years and age of related donor >75 years

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cytarabine
Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
Biological:
• human stem cells
Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate

Locations
Country Name City State
Germany University of Leipzig, Hematology Leipzig

Sponsors (1)
Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event free survival comparison of event free survival (OSHO arm versus Standard intergroup arm) after 5 years
Secondary OS Overall survival at 5 years
Secondary LFS leukemia free survival at 5 years
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