Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell… (NCT05005299) | Clinical Trial Compass
UnknownPhase 1
Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation
Australia18 participantsStarted 2022-06-08
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Acute leukaemia in complete morphologic remission
✓. Myelodysplastic syndrome with less than 10% bone marrow blasts
✓. CLL in complete remission (CR), partial response (PR) or PR with lymphocytosis
✓. NHL in CR or PR
✓. Myeloma in CR, very good partial response (VGPR) or PR within 3 months of prior autologous stem cell transplantation as part of a tandem auto-allo transplant approach
Exclusion criteria
✕. 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
What they're measuring
1
The development of any dose-limiting toxicities
Timeframe: Time point between time of first dose of venetoclax to day 30 post-alloSCT