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TerminatedNCT00125606Updated Dec 18, 2012

Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

A Phase 3 interventional study of conditioning for allogeneic HSCT in Acute Myeloid Leukemia, sponsored by University Hospital Muenster. Terminated at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-12-18.

Sponsored by University Hospital Muenster · Phase 3, Interventional, and Treatment

Why this study was terminated
insufficient patient recruitement
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • AML
  • allogeneic HSCT
  • reduced intensity conditioning
  • randomized trail
03

In context

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with AML in second complete remission
  • HLA-identical related (HLA * A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch
  • Ages 18-60 years
  • Written informed consent from the patient
  • Written informed consent from the donor
  • No major organ dysfunction

Exclusion criteria

Exclusion Criteria:

  • Cardiac failure (New York Heart Association [NYHA] grade II-IV)
  • Renal failure (creatinine > 2.0 mg/dl)
  • Hepatic failure (total bilirubin > 3 mg/dl)
  • Severe neurological/psychiatric disorder
  • Previous allogeneic HSCT
  • Contra-indications for used drugs
  • HIV infection
  • Non-compliance to processing of personal data according to the protocol
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    conditioning therapy with 12 Gy TBI / cyclophosphamide 120

    Procedure: conditioning for allogeneic HSCT

  • Experimental
    conditioning therapy with 8 Gy TBI / fludarabine 120

    Procedure: conditioning for allogeneic HSCT

Interventions

  • Procedureconditioning for allogeneic HSCT
06

What researchers measure

Primary outcomes

  1. treatment related mortality

Secondary outcomes

  1. event free survival

  2. overall survival

  3. cumulative incidence of acute and chronic graft-versus-host disease (GvHD)

  4. activity index (ECOG)

  5. organ function

07

Study locations

1 site
  • Department of Medicine/Hematology and Oncology
    Muenster, NRW 48149, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00125606
Lead sponsor
University Hospital Muenster
Collaborators
Technische Universität Dresden, Philipps University Marburg, Universitätsklinikum Hamburg-Eppendorf, Hannover Medical School, Ludwig-Maximilians - University of Munich, University Hospital, Essen, Johann Wolfgang Goethe University Hospital, Deutsche Klinik fuer Diagnostik, Charite University, Berlin, Germany
Responsible party
Sponsor
First posted
Aug 1, 2005
Start date
Oct 2004
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Dec 18, 2012

Study contacts

Matthias Stelljes, M.D.
principal investigator · Department of Medicine/Hematology and Oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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