Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
Overview
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
Full Title of Study: “Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 18, 2018
Detailed Description
Measuring EFS depending on induction therapy
Interventions
- 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
Arms, Groups and Cohorts
- Active Comparator: standard arm
- standard treatment arm
- Experimental: OSHO – intensified consolidation
- Intermediate dose AraC
- Experimental: OSHO – allografting as consolidation
- allogeneic stem cell Transplantation versus no transplantation
Clinical Trial Outcome Measures
Primary Measures
- Event free survival
- Time Frame: after 5 years
- comparison of event free survival (OSHO arm versus Standard intergroup arm)
Secondary Measures
- OS
- Time Frame: at 5 years
- Overall survival
- LFS
- Time Frame: at 5 years
- leukemia free survival
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of Leipzig
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Dietger Niederwieser, Prof., Principal Investigator, University of Leipzig
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