Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a (AML2004)

January 30, 2024 updated by: University of Leipzig

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measuring EFS depending on induction therapy

Study Type

Interventional

Enrollment (Actual)

1222

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • University of Leipzig, Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • AraC
Experimental: OSHO - intensified consolidation
Intermediate dose AraC
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.
Other Names:
  • AraC
Experimental: OSHO - allografting as consolidation
allogeneic stem cell Transplantation versus no 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event free survival
Time Frame: after 5 years
comparison of event free survival (OSHO arm versus Standard intergroup arm)
after 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: at 5 years
Overall survival
at 5 years
LFS
Time Frame: at 5 years
leukemia free survival
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Dietger Niederwieser, Prof., University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2005

Primary Completion (Actual)

July 18, 2018

Study Completion (Actual)

July 18, 2018

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimated)

December 22, 2011

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSHO#069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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