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

NCT00125606 | Terminated Phase 3 DMC

• 1 other identifier: AML_CR2_allo_HSCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML; allogeneic HSCT; reduced intensity conditioning; randomized trail

Outcome Measures

Primary Outcomes (1)

• treatment related mortality

Secondary Outcomes (5)

• event free survival

• overall survival

• cumulative incidence of acute and chronic graft-versus-host disease (GvHD)

• activity index (ECOG)

• organ function

Study Arms (2)

conditioning therapy with 12 Gy TBI / cyclophosphamide 120

ACTIVE COMPARATOR

Procedure: conditioning for allogeneic HSCT

conditioning therapy with 8 Gy TBI / fludarabine 120

EXPERIMENTAL

Procedure: conditioning for allogeneic HSCT

Interventions

conditioning for allogeneic HSCT PROCEDURE

conditioning therapy with 12 Gy TBI / cyclophosphamide 120; conditioning therapy with 8 Gy TBI / fludarabine 120

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Technische Universität Dresden: collaborator
• Philipps University Marburg: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Hannover Medical School: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• University Hospital, Essen: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• Deutsche Klinik fuer Diagnostik: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Department of Medicine/Hematology and Oncology

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Matthias Stelljes, M.D.

  Department of Medicine/Hematology and Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2005
• First Posted: August 1, 2005
• Study Start: October 1, 2004
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

DE (1)