SWOG clinical trial number
S0125

A Phase II Study of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Older Patients With Acute Myeloid Leukemia (AML) in First Complete Remission (A BMT Study)

Closed
Phase
Accrual
10%
Abbreviated Title
Phase II Elderly AML in First Complete Remission
Activated
04/01/2003
Closed
06/01/2005
Participants
Limited Institutions: Allogeneic BMT Members

Research committees

Leukemia

Treatment

Cyclosporine Filgrastim Fludarabine Phosphate Mycophenolate mofetil

Eligibility Criteria Expand/Collapse

Eligibility Criteria for Patient: Pts. must have a morphologically confirmed diagnosis of AML or secondary AML with FAB classification other than M3. Pts. with M3 AML or blastic transformation of CML are not eligible. Pts. must have received remission induction chemotherapy and must have A1 marrow, B1 blood, and C1 extramedullary disease status. Pts. who have received allogeneic hematopoietic stem cell transplant are not eligible. Pts. who have received any organ transplant for which they remain on immunosuppressive tx are not eligible. Pts. must be within 180 days of their initial diagnosis of AML. Pts. with a history of CNS leukemia must have a lumbar puncture demonstrating the absence of leukemia cells within 7 days before registration. Pts. must have reached their 55th birthdays, but not passed their 70th birthdays. Pts. must have a genotypically HLA-identical sibling who is medically fit, has signed an informed consent to be a donor, and who meets the donor eligibility criteria in the protocol. Pts. must have a Zubrod PS of 0-2. Pts. must have a negative HIV test within 28 days prior to registration. Pts. must be registered on SWOG-9007, the cytogenetics protocol. Pts. must be registered on S9910, the leukemia repository protocol. Pts. must not be pregnant or nursing. Pts. of reproductive potential must have agreed to use an effective contraceptive method. No other prior malignancy is allowed except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt. is currently in complete remission, or any other cancer from which the pt. has been disease-free for 2 yrs.
Eligibility Criteria for Donor: Must be genotypically HLA-identical siblings of their recipients. Must consent to G-CSF administration and leukapheresis. Must be medically fit to undergo apheresis procedure according to institutional guidelines. Must not be monozygotic identical twins of their recipients. Must be greater than or equal to 18 yrs. of age. Must not be pregnant. Must have a negative HIV test within 28 days prior to the patient's registration.