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

This study is currently recruiting participants.
Verified March 2011 by University of Leipzig
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
History of Changes
  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:

Drug Information available for: Cytarabine
U.S. FDA Resources

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:
AML 2004 OSHO #069 (Elderly)  This link exits the ClinicalTrials.gov site

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 May 22, 2013