A California Cooperative Clinical Study Comparing Allogeneic Hematopoietic Cell Transplantation Using Nonmyeloablative Host Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin Versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission

Acute myeloid leukemia (AML) is a cancer of the bone marrow that mostly affects older adults. Even with the best chemotherapy, two-year disease-free survival is achieved in a minority of patients. Bone marrow transplantation from a sibling donor may improve cure rates; however, patients over 50 years of age have a high risk of complications and therefore generally are excluded from this treatment option. Recently our group developed a transplantation strategy for older cancer patients that protects against transplant-associated complications, yet does not interfere with the ability of the transplanted donor cells to destroy cancer cells. With this new method, we can now safely evaluate transplantation as a curative therapy for AML patients over the age of 50. We have assembled clinical and scientific researchers throughout the state of California to study and compare bone marrow transplantation using our new approach with the best standard of care chemotherapy in AML patients over the age of 50. The results of this study have the potential to establish a new treatment standard that will improve survival of older AML patients.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Anti-Thymocyte Globulin
  • drug : Cellcept
  • drug : Cyclosporine
  • procedure : Hematopoietic Cell Transplantation

Phase: Phase 3

Eligibility

Ages Eligible For Study:

50 Years - 75 Years

Inclusion Criteria

Both genders and individuals from all ethnic groups will be eligible. 1. Patients greater than or equal to 50 years of age and less than or equal to 75 years of age. 2. Patients with de novo AML based on FAB and WHO criteria. 3. Patients with intermediate or unfavorable cytogenetic abnormalities based on SWOG Cytogenetic Criteria. 4. Patients achieving a 1st morphologic CR, or CRp (a complete remission but with low platelets) following one or two courses of induction therapy. (See definition of CR on page 6.) CR must be documented no more than 8 weeks prior to the date of enrollment. 5. Patients fit for nonmyeloablative transplantation or best treatment. 6. Patients able to understand and willing to sign a written informed consent document.

External Links

Explore related trials

Contact information

Primary Contact:

BMT Referrals 650-725-1647

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Stanford Medicine Resources:

Footer Links: