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

Acute Myeloid Leukemia Clinical Trial

Official title:

Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00125606
• Other study ID #: AML_CR2_allo_HSCT
• Status: Terminated
• Phase: Phase 3
• First received: July 26, 2005
• Last updated: December 17, 2012
• Start date: October 2004
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• conditioning for allogeneic HSCT

Locations

Country	Name	City	State
Germany	Department of Medicine/Hematology and Oncology	Muenster	NRW

Sponsors (10)

Lead Sponsor	Collaborator
University Hospital Muenster	Charite University, Berlin, Germany, Deutsche Klinik fuer Diagnostik, Hannover Medical School, Johann Wolfgang Goethe University Hospitals, Ludwig-Maximilians - University of Munich, Philipps University Marburg Medical Center, Technische Universität Dresden, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment related mortality
Secondary	event free survival
Secondary	overall survival
Secondary	cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
Secondary	activity index (ECOG)
Secondary	organ function