Clinical Trial Detail

The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC) versus reduced intensity conditioning (RIC) regimens.

Ages Eligible for Study: 18 Years to 65 Years

Genders Eligible for Study: Both

Age equal or less than 65 years old and equal to or greater than 18 years old.

- Patients with the diagnosis of MDS or AML with fewer than 5% myeloblasts in the bone marrow and no myeloblasts in the peripheral blood on morphologic analysis performed within 30 days of start of the conditioning regimen. Pre-transplant bone marrow sample must be evaluable for assessment of remission status (i.e. aspirate smear containing particles and/or evaluable bone marrow core biopsy).

- For patients receiving treatment of their MDS or AML prior to transplantation: a)Interval between the start of a cycle of conventional cytotoxic chemotherapy and the start of conditioning regimen must be at least 30 days; b)Interval between completing treatment with a hypomethylating agent or other non-cytotoxic chemotherapy and the start of conditioning regimen must be at least 10 days.

- HCT-Specific Comorbidity Index Score (HCT-CI) less than or equal to 4.

- Organ function: a) Cardiac function: Symptomatic coronary artery disease or ejection fraction greater than or equal to 40%; b) Hepatic function: total bilirubin less than or equal to 2 times the upper limit of normal and ALT and AST less than or equal to 3 times the upper limit of normal.; c)Pulmonary function: DLCO greater than or equal to 40%, FEV1 greater than or equal to 50% (corrected for hemoglobin.

- Creatinine clearance greater than or equal to 50mL/min/1.73m^2.

- Signed informed consent.

Other eligibility criteria may apply.

- Circulating peripheral blood myeloblasts on morphologic analysis from time of last treatment to time of enrollment.

- Prior allograft or prior autograft.

- Active CNS disease as identified by positive CSF cytospin at time of enrollment.

- Karnofsky Performance Score less than 70.

- Patients receiving supplemental oxygen.

- Planned use of DLI therapy.

- Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms).

- Patients seropositive for the human immunodeficiency virus (HIV).

- Patients with prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ or other cancer treated with curative intent greater than 5 years previously. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.

- Females who are pregnant or breastfeeding.

- Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment.

- Patients unable to communicate in English will be excluded from collection of patient-reported outcomes.

Other exclusion criteria may apply.