CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
Sponsor: Fred Hutchinson Cancer Center • ClinicalTrials.gov ID: NCT04375631
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This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells called graft versus host disease. Giving cyclophosphamide, cyclosporine, and mycophenolate mofetil after the transplant may stop this from happening.
Interventions
-
Cladribine
(Drug)
Given IV
-
Cyclophosphamide
(Drug)
Given IV
-
Cyclosporine
(Drug)
Given IV then PO
-
Cytarabine
(Drug)
Given IV
-
Filgrastim
(Biological)
Given SC
-
Hematopoietic Cell Transplantation
(Procedure)
Undergo HCT
-
Mitoxantrone
(Drug)
Given IV
-
Mycophenolate Mofetil
(Drug)
Given IV or PO
-
Mycophenolate Sodium
(Drug)
Given PO
-
Total-Body Irradiation
(Radiation)
Undergo TBI
-
Idarubicin
(Drug)
Given IV
-
Fludarabine
(Drug)
Given IV
-
Cytarabine
(Drug)
Given IV
-
Multigated Acquisition Scan
(Procedure)
Undergo MUGA
-
Echocardiography Test
(Procedure)
Undergo ECHO
-
X-Ray Imaging
(Procedure)
Undergo x-ray
-
Bone Marrow Biopsy
(Procedure)
Undergo bone marrow biopsy and aspirate
-
Bone Marrow Aspiration
(Procedure)
Undergo bone marrow biopsy and aspirate
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
Eligibility criteria
Conditions
Locations
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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