OncoMatch/Clinical Trials/NCT06013423
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
Is NCT06013423 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute leukemia of ambiguous lineage.
Treatment: Cyclophosphamide · Cyclosporine · Fludarabine Phosphate · Mycophenolate Mofetil · Thiotepa — This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Chronic Myeloid Leukemia
Biomarker criteria
Allowed: BCR t(9;22)
Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.
Allowed: TCF3 t(1;19)
Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.
Allowed: KMT2A (MLL) t(4;11)
Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.
Allowed: KMT2A (MLL) MLL rearrangement (11q23)
Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.
Prior therapy
Must have received: tyrosine kinase inhibitor — chronic phase CML
To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.
Cannot have received: checkpoint inhibitor
Prior checkpoint inhibitors/ blockade in the last 12 months.
Cannot have received: stem cell transplant
Exception: Two prior stem cell transplants of any kind; one prior autologous stem cell transplant within the preceding 12 months; prior allogeneic transplantation
Two prior stem cell transplants of any kind. One prior autologous stem cell transplant within the preceding 12 months. Prior allogeneic transplantation.
Cannot have received: involved field radiation therapy
Exception: would preclude safe delivery of 400cGy total body irradiation (TBI)
Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.
Lab requirements
Blood counts
ANC > 0.2 (growth factor supported if necessary) at transplant work-up
Kidney function
Calculated creatinine clearance > 70 ml/min
Liver function
Bilirubin < 1.5 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis); ALT < 3 x ULN
Cardiac function
Left ventricular ejection fraction > 50%
Calculated creatinine clearance > 70 ml/min. Bilirubin < 1.5 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis). Alanine transaminase (ALT) < 3 x upper limit of normal (ULN). Left ventricular ejection fraction > 50%. ANC > 0.2 (growth factor supported if necessary) at transplant work-up.
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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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