Trial Search Results

Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML

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 currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Genzyme, a Sanofi Company


  • Procedure: Hematopoietic Cell Transplantation
  • Drug: Anti-Thymocyte Globulin
  • Drug: Cyclosporine
  • Drug: Cellcept


Phase 3


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.

Exclusion Criteria:

   1. Patients with AML with favorable cytogenetic features based on SWOG Cytogenetic

   2. Patients not in a Complete Remission at time of enrollment.

   3. Patients with treatment-related or MDS-related AML.

   4. CR documented >8 weeks prior to date of enrollment.

   5. Patients with active CNS disease as identified by positive CSF cytospin at time of

   6. Patients with prior or concurrent malignancies except localized non-melanoma skin
   malignancies or treated cervical carcinoma in situ. Cancer treated with curative
   intent <5 years previously will not be allowed. Cancer treated with curative intent >5
   years previously will be allowed. Patients with low grade lymphomas are eligible as
   long as they have not and do not require active treatment for control of their

   7. Patients planned for allogeneic transplant using a full-dose conditioning,
   irrespective of knowledge of donor status.

   8. Patients whose life expectancy is severely limited (<1 year) by diseases other than

   9. Karnofsky Performance Score <60.

10. Patients who are pregnant or breastfeeding.

11. Patients who are HIV seropositive.

12. Patients who have an uncontrolled infection (presumed or documented) with progression
   after appropriate therapy for greater than one month.

13. Patients with symptomatic coronary artery disease, uncontrolled congestive heart
   failure. Left Ventricular Ejection Fraction is not required to be measured, however if
   it is measured, patient is excluded if ejection fraction is <30%.

14. Patients requiring supplementary continuous oxygen. DLCO is not required to be
   measured, however if it is measured, patient is excluded if DLCO <35%.

15. Patients with clinical or laboratory evidence of liver disease will be evaluated for
   the cause of liver disease, its clinical severity in terms of liver function and
   histology, and for the degree of portal hypertension. Patients with any of the
   following liver function abnormalities will be excluded:

      1. Fulminant liver failure.

      2. Cirrhosis with evidence of portal hypertension or bridging fibrosis.

      3. Alcoholic hepatitis.

      4. Esophageal varices.

      5. A history of bleeding esophageal varices.

      6. Hepatic encephalopathy.

      7. Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the
      prothrombin time.

      8. Ascites related to portal hypertension.

      9. Chronic viral hepatitis with total serum bilirubin >3 mg/dL.

   10. Symptomatic biliary disease.

Ages Eligible for Study

50 Years - 75 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
Not Recruiting