Brief Summary
The purpose of this study is to investigate the safety of oral venetoclax treatment prior to fludarabine and cyclophosphamide non-myeloablative conditioning allogeneic stem cell transplantation for patients with haematological malignancies.
Intervention/Treatment
- Drug: Venetoclax
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Allogeneic stem cell transplantation (alloSCT).
Inclusion Criteria
Patients are eligible for inclusion if all of the following criteria are met:
- Age greater than or equal to 18 years.
- Planned to undergo allogeneic stem cell transplantation for one of the following haematological malignancies: acute leukaemia (including myeloid and/or lymphoid lineage or biphenotypic), myelodysplastic syndrome, chronic lymphocytic leukaemia (CLL), B-cell non-Hodgkin lymphoma (NHL) and plasma cell myeloma.
- Physician preference for a non-myeloablative conditioning regimen.
- Available 10/10 HLA-matched related or unrelated haematopoietic stem cell donor.
- Transplantation to be performed from a peripheral blood stem cell source.
- Adequate renal and hepatic function at screening as follows:
- Calculated creatinine clearance >50ml/min as measured by Cockroft Gault formula.
- AST and ALT less than or equal to 3.0 x ULN.
- Bilirubin less than or equal to 1.5 x ULN (except patients with Gilbert’s Syndrome).
- Able to tolerate oral medications.
- Disease status at the time of transplantation as follows:
- Acute leukaemia in complete morphologic remission.
- Myelodysplastic syndrome with less than 10% bone marrowsoft, spongy tissue found in bones that makes blood cells blasts.
- CLL in complete remission (CR), partial response (PR) or PR with lymphocytosis.
- NHL in CR or PR.
- Plasma cell 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.
- ECOG performance status 0-1.