OncoMatch/Clinical Trials/NCT05005299
Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation
Is NCT05005299 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Venetoclax and Fludarabine for leukemia, myeloid, acute.
Treatment: Venetoclax · Fludarabine · Cyclophosphamide — This is a Phase 1, open-label, single center study of short-course oral venetoclax therapy prior to non-myeloablative conditioning with fludarabine and cyclophosphamide in subjects with haematological malignancies who are planned for allogeneic stem cell transplantation (alloSCT). The primary study objective is to determine the safety and maximum tolerated dose of venetoclax when used in combination with fludarabine and cyclophosphamide conditioning. Secondary objectives were to evaluate the transplant outcomes and donor/recipient engraftment of this regimen.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: autologous stem cell transplant — myeloma, as part of tandem auto-allo transplant approach
myeloma in CR, VGPR or PR within 3 months of prior autologous stem cell transplantation as part of a tandem auto-allo transplant approach
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplantation
Cannot have received: BCL-2 inhibitor (venetoclax)
Exception: with the exception of cytopenias
Prior intolerance of venetoclax or another BCL-2 inhibitor with the exception of cytopenias. Patients with prior clinical tumour lysis syndrome following venetoclax or other BCL-2 inhibitor will be excluded from the study if at the time of prior TLS their disease burden was as follows: For CLL: Diameter of any lymph node or tumour mass <5cm OR absolute lymphocyte count≤25x10^9/L; For NHL: Diameter of any lymph node or tumour mass <5cm
Lab requirements
Kidney function
Calculated creatinine clearance >50ml/min as measured by Cockroft Gault formula
Liver function
AST and ALT ≤ 3.0 x ULN; Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's Syndrome)
Adequate renal and hepatic function at screening as follows: Calculated creatinine clearance >50ml/min as measured by Cockroft Gault formula; AST and ALT ≤ 3.0 x ULN; Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's Syndrome)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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