NCT00150878

Brief Summary

The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mg/kg Cyclophosphamide.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

6 years

First QC Date

September 6, 2005

Last Update Submit

June 19, 2013

Conditions

Acute Myeloid Leukemia

Keywords

Reduced-intensity conditioningFludarabineAcute myeloid LeukemiaTreatment-related mortality

Outcome Measures

Primary Outcomes (1)

  • Treatment-related mortality at 12 months after transplantation

    Proportion of patients dying without prior relapse

    12 months

Secondary Outcomes (2)

  • Disease-free and Overall survival

    5 years

  • Grade 3-4 extramedullary toxicity

    100 days

Study Arms (2)

12 Gy/Cyclophosphamide

OTHER

Standard intensity conditioning

Other: Conditioning therapy

8 Gy /Fludarabine

EXPERIMENTAL

Reduced-intensity conditioning

Other: Conditioning therapy

Interventions

Conditioning therapyOTHER

Preparation before allogeneic transplantation

12 Gy/Cyclophosphamide8 Gy /Fludarabine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of acute myeloid leukemia in first remission
  • Standard-or high-risk marrow cytogenetics
  • HLA-matched related or unrelated donor available (in case of high-risk disease)
  • Age 18 to 60
  • Informed consent
  • Consent of donor to donate peripheral blood stem cells
  • sufficient liver function (elevation of transferases \< 2.5 x upper limit)

You may not qualify if:

  • AML with t(5;17)
  • AML with t((8;21)
  • clinically relevant heart failure (NYHA II-IV)
  • Renal failure (creatinine \> 200 µg/ml)
  • Liver function failure (bilirubin \> 3 mg/dl)
  • Concomitant Neurological or psychiatric disease
  • Contraindications to receive prescribed study medication
  • HIV infection
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik und Poliklinik I

Dresden, 01307, Germany

Location

Related Publications (3)

  • Stelljes M, Bornhauser M, Kroger M, Beyer J, Sauerland MC, Heinecke A, Berning B, Scheffold C, Silling G, Buchner T, Neubauer A, Fauser AA, Ehninger G, Berdel WE, Kienast J; Cooperative German Transplant Study Group. Conditioning with 8-Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia. Blood. 2005 Nov 1;106(9):3314-21. doi: 10.1182/blood-2005-04-1377. Epub 2005 Jul 14.

    PMID: 16020510BACKGROUND

  • Fasslrinner F, Schetelig J, Burchert A, Kramer M, Trenschel R, Hegenbart U, Stadler M, Schafer-Eckart K, Batzel M, Eich H, Stuschke M, Engenhart-Cabillic R, Krause M, Dreger P, Neubauer A, Ehninger G, Beelen D, Berdel WE, Siepmann T, Stelljes M, Bornhauser M. Long-term efficacy of reduced-intensity versus myeloablative conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: retrospective follow-up of an open-label, randomised phase 3 trial. Lancet Haematol. 2018 Apr;5(4):e161-e169. doi: 10.1016/S2352-3026(18)30022-X. Epub 2018 Mar 14.

    PMID: 29550384DERIVED

  • Bornhauser M, Kienast J, Trenschel R, Burchert A, Hegenbart U, Stadler M, Baurmann H, Schafer-Eckart K, Holler E, Kroger N, Schmid C, Einsele H, Kiehl MG, Hiddemann W, Schwerdtfeger R, Buchholz S, Dreger P, Neubauer A, Berdel WE, Ehninger G, Beelen DW, Schetelig J, Stelljes M. Reduced-intensity conditioning versus standard conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: a prospective, open-label randomised phase 3 trial. Lancet Oncol. 2012 Oct;13(10):1035-44. doi: 10.1016/S1470-2045(12)70349-2. Epub 2012 Sep 7.

    PMID: 22959335DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gerhard Ehninger, MD

    Director of Med. Klink und Poliklinik I, Technical University Dresden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

December 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

DE(1)