Phase
Condition
Leukemia
Chronic Myeloid Leukemia
Treatment
N/AClinical Study ID
Ages 1-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with CML, AML, MDS or ALL relapsed after related or unrelated donorallogeneic marrow transplantation.
Patients must be within one year of identification of relapse or if beyond that timeperiod, must have some evidence of donor DNA by RFLP or cytogenetics.
Patients may have evidence of relapse based on molecular, cytogenetic or morphologiccriteria.
CML patients must have cytogenetic evidence of relapse or if Ph negative to start,obvious evidence of relapse other than minimal residual disease.
Patients must have <30% marrow blasts on a marrow biopsy performed within two weeks ofthe first donor lymphocyte infusion.
Patients with >30% blasts can become eligible for donor lymphocytes after reinductionwith any standard therapy regimen.
Patients with AML, MDS or ALL achieving a CR with standard therapy regimens areeligible for this protocol.
Patients who relapse with their initial disease or develop a second malignancy afterrelated or unrelated donor allogeneic marrow transplantation with other initialdiagnoses (such as but not limited to CLL, lymphoma, myeloma, juvenile CML, sarcoma,breast cancer) may also be included in this protocol. Patients will be eligible withor without other adjunct chemotherapy or radiation therapy. Post-transplant lymphomas (often referred to as EBV-associated lymphomas) will be eligible for donor leukocyteinfusions on this protocol. Treatment with donor leukocytes under this protocol isrestricted to malignant diseases only. Graft failure or relapse of non-malignantdisorders is excluded from receiving donor leukocyte infusions on this protocol.Autologous transplant patients who relapse are not eligible for this protocol.Patients with malignant diseases amenable to other curative therapy are not eligible (i.e. skin cancers).
Exclusion
Exclusion Criteria:
Patients with concurrent signs of acute or chronic graft-versus-host disease requiringongoing treatment at the time of relapse will be ineligible.
Patients with >30% marrow blasts at the time of therapy will be ineligible.
Patients on prednisone, cyclosporine, Imuran or other immunosuppressive medicationsare not eligible until these medications are discontinued for at least 2 weeks withouta flare of GVHD.
CML patients in complete cytogenetic remission who are bcr/abl positive by PCR onlyare not eligible.
Study Design
Study Description
Connect with a study center
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesSite Not Available

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