This phase I study is assessing the safety and appropriate dose level of targeted therapy (venetoclax) before treatment with chemotherapy drugs (fludarabine and cyclophosphamide) in people with certain blood cancers or disorders who are planned to undergo allogenic haematopoietic stem cell transplantation.
This trial is treating patients with acute leukaemia, myelodysplastic syndrome, chronic lymphocytic leukaemia, B-cell non-Hodgkin lymphoma, and plasma cell lymphoma.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
The VICTORY Study: A Phase I Study of Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation
Other Non-Commercial Sponsor
Melbourne Health
Summary
Eligible participants will be enrolled sequentially into one of 4 treatment dose level cohorts to receive short-course oral venetoclax on day-11 to -6, followed by intravenous fludarabine 30mg/m2 daily (day -5 to -3) and intravenous cyclophosphamide 750mg/m2 daily (day-5 to -3). Allogenic stem cell infusion will occur on day 0. in the dose-escalation phase of this 3+3 study, three participants are planned for each Dose Level. The dose-expansion phase of this study involves recruitment of up to 12 participants at the Maximum Tolerated Dose (MTD) level.
Recruiting Hospitals Read More