Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic … (NCT07565220) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
United States48 participantsStarted 2026-06-01
Plain-language summary
This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:
✓. Age 50-70 years old or
✓. Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician
✓. Patients have one of the following diagnoses:
✓. Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\<5% marrow blasts by morphology).
✓. Acute myeloid leukemia (AML) in first or subsequent morphological remission (\<5% marrow blasts by morphology) with or without hematologic recovery.
✓. Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, mast cell leukemia or chronic myeloid leukemia with blast crisis) in first or subsequent morphological remission (\<5% marrow blasts by morphology) with or without hematologic recovery.
✓. Myelodysplastic syndrome (MDS) with a history of excess blasts, with \>5% marrow blasts by morphology after receiving at least one cycle of treatment, including but not limited to hypomethylating agent, BCL-2 inhibitor, cytoreductive chemotherapy.
Exclusion criteria
✕. Poor performance status with Karnofsky Score \<70%