Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission - Full Text View

Sponsored by:	University Hospital Carl Gustav Carus
Information provided by:	University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:	NCT00150878

Purpose

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Procedure: Conditioning therapy	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission

Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:

Treatment-related mortality at 12 months after transplantation

Secondary Outcome Measures:

Disease-free and Overall survival
Grade II-IV acute Graft-versus-Host disease
Grade 3-4 extramedullary toxicity

Estimated Enrollment:	172
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2008

Detailed Description:

Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.

In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.

Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.

After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.

The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.6 and a first-error of 5%, 164 patients will have to be randomized.

Secondary endpoints include:

3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity

Eligibility

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

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150878

Contacts

Contact: Martin Bornhäuser, MD	+49351458 ext 4704	martin.bornhaeuser@uniklinikum-dresden.de
Contact: Catrin Theuser	+49351 458 ext 2869	catrin.theuser@uniklinikum-dresden.de

Locations

Germany
Medizinische Klinik und Poliklinik I	Recruiting
Dresden, Germany, 01307
Contact: Martin Bornhäuser, MD +49351458 ext 4704 martin.bornhaeuser@uniklinikum-dresden.de

Sponsors and Collaborators

University Hospital Carl Gustav Carus

Investigators

Study Director:

Gerhard Ehninger, MD

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

More Information

Central Leukemia Study Group This link exits the ClinicalTrials.gov site

Publications:

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. Conditioning with 8 Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia. Blood. 2005 Jul 14; [Epub ahead of print]

Study ID Numbers:	9005-2003
Study First Received:	September 6, 2005
Last Updated:	April 12, 2007
ClinicalTrials.gov Identifier:	NCT00150878
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Carl Gustav Carus:

Reduced-intensity conditioning
Fludarabine
Acute myeloid Leukemia
Treatment-related mortality

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Fludarabine
Fludarabine monophosphate

Cyclophosphamide
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009