Clinical trial NCT00125606: Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: AML
allogeneic HSCT
reduced intensity conditioning
randomized trail
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
name: Philipps University Marburg
name: Universitätsklinikum Hamburg-Eppendorf
name: Hannover Medical School
name: Ludwig-Maximilians - University of Munich
name: University Hospital, Essen
name: Johann Wolfgang Goethe University Hospital
name: Deutsche Klinik fuer Diagnostik
name: Charite University, Berlin, Germany
First posted: 2005-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: treatment related mortality
Secondary outcomes:
measure: event free survival
measure: overall survival
measure: cumulative incidence of acute and chronic graft-versus-host disease (GvHD)
measure: activity index (ECOG)
measure: organ function
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Medicine/Hematology and Oncology
state: NRW
Study officials:
affiliation: Department of Medicine/Hematology and Oncology
name: Matthias Stelljes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: