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

Intervention(s):

  • Procedure: Allogeneic HSCT
  • Drug: Anti-thymocyte globulin (ATG)
  • Drug: Cyclosporine (CSP)
  • Drug: Mycophenolate mofetil (MMF)
  • Radiation: Total lymphoid irradiation (TLI)
  • Drug: Methylprednisolone sodium succinate
  • Drug: Best standard care

Phase:

Phase 3

Eligibility


INCLUSION CRITERIA

   - ≥ 50 years of age and ≤ 75 years of age.

   - De novo acute myelogenous leukemia (AML), based on FAB and WHO criteria.

   - Intermediate or unfavorable cytogenetic abnormalities based on Southwest Oncology
   Group (SWOG) Cytogenetic Criteria.

   - First morphologic complete remission (CR), or CRp (a complete remission but with low
   platelets) following 1 or 2 courses of induction therapy, documented no more than 8
   weeks prior to the date of enrollment and confirmed at time of enrollment.

   - Karnofsky Performance Score ≥ 60.

   - Suitable for non-myeloablative transplantation or best treatment.

   - Able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA

   - AML with favorable cytogenetic features based on SWOG Cytogenetic Criteria

   - AML, either treatment-related or MDS-related

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

   - Prior or concurrent malignancies except localized non-melanoma skin malignancies or
   treated cervical carcinoma in situ. (EXCEPTION: Cancer treated with curative intent >
   5 years previously is allowed. EXCEPTION: Low grade lymphoma is allowed as long as
   active treatment is not required for control of disease)

   - Planned for allogeneic transplant using a full-dose conditioning

   - Life expectancy < 1 year due to diseases other than malignancy

   - Pregnant or breastfeeding.

   - HIV-seropositive.

   - Uncontrolled infection (presumed or documented) with progression after appropriate
   therapy for greater than one month.

   - Symptomatic coronary artery disease or uncontrolled congestive heart failure. Left
   ventricular ejection fraction (LVEF) is not required to be measured, however if
   measured, exclusion if ejection fraction is < 30%.

   - Requiring supplementary continuous oxygen. Diffusing capacity of the lungs for carbon
   monoxide (DLCO) is not required to be measured, however if it is measured, exclusion
   if DLCO < 35%.

   - Fulminant liver failure

   - Cirrhosis with evidence of portal hypertension or bridging fibrosis

   - Alcoholic hepatitis

   - Esophageal varices

   - A history of bleeding esophageal varices

   - Hepatic encephalopathy

   - Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the
   prothrombin time

   - Ascites related to portal hypertension

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

   - Symptomatic biliary disease

Ages Eligible for Study

50 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
650-725-1647
Not Recruiting