Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Trans… (NCT04994808) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia
United States23 participantsStarted 2023-08-11
Plain-language summary
This phase II trials studies the effect of treosulfan-based versus clofarabine-based conditioning regimens before donor hematopoietic stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Chemotherapy drugs, such as treosulfan, fludarabine, and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body irradiation before a donor hematopoietic 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. This study may help doctors determine whether treosulfan-based or clofarabine-based conditioning regimen works better before donor hematopoietic stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Age \>= 18 years and =\< 75 years
* Diagnosis of MDS-EB or AML: must have \< 5% marrow blasts (by morphology and/or flow cytometry) at time of transplant
* Karnofsky performance score (KPS) \>= 60% on pre-HCT evaluation
* Able to give informed consent
* Patients with previous autologous or allogeneic HCT may enroll
* DONOR: Human leukocyte antigen (HLA)-identical related donors or unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for only one HLA allele at class I is allowed
* DONOR: Donors able to undergo peripheral blood stem cell collection. Only granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cell (PBSC) will be permitted as an hematopoietic stem cell (HSC) source on this protocol
Exclusion Criteria:
* Presence of circulating blasts (in the blood) detected by standard pathology for patients with AML
* Presence of \>= 5% circulating leukemic blasts (in the blood) detected by standard pathology for patients with MDS-EB
* Patients with promyelocytic AML
* Organ dysfunction
* Cardiac: Ejection fraction \< 35% (or, if unable to obtain ejection fraction, shortening fraction of \< 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease. Patients with a shortening fraction \< 26% may be enrolled if approved by a cardiologist
* Pulmonary:
* Diffusion capacity of the lung for carbon monoxide (DLCO) \< 40%…