David Miklos
Allogeneic HCT using Nonmyeloablative Host Conditioning with TLI & ATG vs SOC in AML
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: Hematopoietic Cell Transplantation
Phase:
Phase 3Eligibility
Ages Eligible for Study:
50 years to 75 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key Exclusion Criteria:
1. Patients with AML with favorable cytogenetic features based on SWOG Cytogenetic Criteria.
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 enrollment.
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 disease.
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 malignancy.
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:
a.Fulminant liver failure.
b.Cirrhosis with evidence of portal hypertension or bridging fibrosis.
c.Alcoholic hepatitis.
d.Esophageal varices.
e.A history of bleeding esophageal varices.
f.Hepatic encephalopathy.
g.Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time.
h.Ascites related to portal hypertension.
i.Chronic viral hepatitis with total serum bilirubin >3 mg/dL.
j.Symptomatic biliary disease.
Additional Study Details
Official Title:
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 RemissionAnticipated start date:
8/21/2007Lead Sponsor:
Stanford UniversityCollaborator(s):
- NIH
- Genzyme Corporation
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Overall survival defined as the date of documented CR until the dte of the latest follow-up or death by any cause
Secondary Outcomes:
- To determine if NMA HCT leads to a superior disease free survival (DFS) compared to conventional therapy
- To determine the relapse rates and non-relapse mortality in both arms of the study
- To determine in the transplant recipients the 100 day and six month transplant related mortality
- To determine in the transplant recipients the incidence of complete donor hematopoietic cell chimerism and of primary graft loss
- To determine the percentage of patients completing the intended therapy in both arms
Total Number to be Enrolled:
150Total Number to be Enrolled at Stanford:
50More Information
Secondary ID(s):
- 97843
- BMT190
- NCT00568633
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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