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

University Hospital Muenster

Status and phase: Terminated; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Procedure: conditioning for allogeneic HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT00125606

AML_CR2_allo_HSCT

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

conditioning therapy with 12 Gy TBI / cyclophosphamide 120

Active Comparator group

Treatment:

Procedure: conditioning for allogeneic HSCT

conditioning therapy with 8 Gy TBI / fludarabine 120

Experimental group

Treatment:

Procedure: conditioning for allogeneic HSCT