OncoMatch/Clinical Trials/NCT04195633
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
Is NCT04195633 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute leukemia.
Treatment: Cyclophosphamide · Cyclosporine · Filgrastim · Fludarabine · Mycophenolate Mofetil · Mycophenolate Sodium · Treosulfan — This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Chronic Myeloid Leukemia
Hodgkin Lymphoma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: ABL1 fusion
Required: BCR fusion
Prior therapy
Must have received: tyrosine kinase inhibitor — chronic myelogenous leukemia (CML) in first chronic phase
To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor
Must have received: any systemic therapy — low grade lymphoma (CLL/SLL, marginal zone lymphoma, follicular lymphoma)
low grade lymphoma (CLL/SLL, marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR/PR
Must have received: any systemic therapy — large cell lymphoma
Large cell lymphoma in > second CR (CR2)/ >= PR2
Must have received: initial therapy — mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia
Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR/PR
Lab requirements
Kidney function
Creatinine < 2.0 mg/dl (adults) or estimated creatinine clearance > 40 ml/min (pediatrics); adults with creatinine > 1.2 or history of renal dysfunction must have estimated creatinine clearance > 40 ml/min
Liver function
Total bilirubin < 2 x ULN unless related to Gilbert's disease or hemolysis; AST and ALT <= 2.5 x ULN; Alkaline phosphatase <= 5 x ULN
Cardiac function
Absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction >= 40% or shortening fraction > 22%
Adequate cardiac function... Adequate pulmonary function... Total bilirubin < 2 x ULN unless felt to be related to Gilbert's disease or hemolysis; AST and ALT <= 2.5 x ULN; Alkaline phosphatase <= 5 x ULN; Creatinine < 2.0 mg/dl (adults) or estimated creatinine clearance > 40 ml/min (pediatrics)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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