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

Phase 3

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: conditioning for allogeneic HSCT

• Registration Number: NCT00125606
• Lead Sponsor: University Hospital Muenster

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-29
• Study First Posted: 2005-08-01
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conditioning therapy with 12 Gy TBI / cyclophosphamide 120	conditioning for allogeneic HSCT	-
conditioning therapy with 8 Gy TBI / fludarabine 120	conditioning for allogeneic HSCT	-

Primary Outcome Measures

Name	Time	Method
treatment related mortality

Secondary Outcome Measures

Name	Time	Method
event free survival
overall survival
cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
activity index (ECOG)
organ function

Trial Locations

Locations (1)

Department of Medicine/Hematology and Oncology; 🇩🇪 Muenster, NRW, Germany