Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
Recruitment status was Recruiting
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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.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Procedure: conditioning for allogeneic HSCT |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Randomized Phase 3 Trial for Patients With AML in CR2 Comparing TBI 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide |
- treatment related mortality
- event free survival
- overall survival
- cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
- activity index (ECOG)
- organ function
Estimated Enrollment: | 172 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
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:
- 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
Germany | |
Department of Medicine/Hematology and Oncology | Recruiting |
Muenster, NRW, Germany, 48149 | |
Contact: Matthias Stelljes, M.D. +49 251 83-52801 stelljes@uni-muenster.de | |
Principal Investigator: Matthias Stelljes, M.D. |
Principal Investigator: | Matthias Stelljes, M.D. | Department of Medicine/Hematology and Oncology |
No publications provided
Responsible Party: | University of Muenster |
ClinicalTrials.gov Identifier: | NCT00125606 History of Changes |
Other Study ID Numbers: | AML_CR2_allo_HSCT |
Study First Received: | July 26, 2005 |
Last Updated: | June 24, 2010 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Muenster:
AML allogeneic HSCT reduced intensity conditioning randomized trail |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cyclophosphamide Fludarabine Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on October 16, 2012