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Complete title: A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
|Research Study Number||2497.00|
|Principal Investigator||Bart Scott, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
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.
Exclusions (conditions that would prevent participation in this study)
- 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.
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)
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