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Bone Marrow Transplant

Reduced Intensity Conditioning vs.Myeloablative Conditioning for AML or MDS (2497)
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
Status Conditions Phase Study ID
Closed Acute Myeloid Leukemia (AML); Myelodysplastic Syndromes (MDS) Phase III 2497
NCT01339910
Summary

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.


Investigator
Bart Scott, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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.
Exclusions (conditions that would prevent participation in this study)
  • 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.
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.