Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a (AML 2004)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT01497002
First received: December 21, 2011
Last updated: December 22, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Acute Myeloid Leukaemia
Drug: Cytarabine
Biological: human stem cells
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm. Efficacy of Allogeneic Stem Cell Transplantation in Comparison to a Second Consolidation Chemotherapy in Elderly Patients With Newly Diagnosed AML in the Age Over 60 Years

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • comparison of event free survival (OSHO arm versus Standard intergroup arm) [ Time Frame: after 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 730
Study Start Date: April 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard arm
standard treatment arm
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.
Experimental: OSHO - intensified consolidation Drug: Cytarabine
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 (2 courses): 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.
Experimental: OSHO - allografting as consolidation
allogeneic stem cell transplantation
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497002

Contacts
Contact: Dieter Niederwieser, Prof. +4934197 ext 13050 dietger@medizin.uni-leipzig.de

Locations
Germany
University of Leipzig, Hematology Recruiting
Leipzig, Germany, 04103
Principal Investigator: Dietger Niederwieser         
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Dietger Niederwieser, Prof. University of Leipzig, Germany
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01497002     History of Changes
Other Study ID Numbers: OSHO#069
Study First Received: December 21, 2011
Last Updated: December 22, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University of Leipzig:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014