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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