RecruitingPhase 1NCT05005299

Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation

The VICTORY Study: A Phase I Study of Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation


Sponsor

Melbourne Health

Enrollment

18 participants

Start Date

Jun 8, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called venetoclax to the preparation regimen (conditioning) before a stem cell transplant improves outcomes for people with blood cancers undergoing a type of transplant that uses a less-intensive conditioning approach. **You may be eligible if...** - You are 18 or older with a blood cancer such as leukemia, lymphoma, myelodysplastic syndrome (MDS), or multiple myeloma - You are planned to undergo a stem cell transplant with a reduced-intensity (non-myeloablative) conditioning regimen - You have a matched stem cell donor available (10/10 HLA match, related or unrelated) - Your kidney and liver function are adequate **You may NOT be eligible if...** - You are not planned for a stem cell transplant - You do not have a suitable matched donor - Your kidney or liver function is too impaired - Your cancer type is not one of those specified Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

Venetoclax is administered as an oral tablet once daily.

DRUGFludarabine

Fludarabine is administered as an intravenous infusion at a dose of 30mg/m2 daily, to be administered over 30 minutes.

DRUGCyclophosphamide

Cyclophosphamide is administered as an intravenous infusion at a dose of 750mg/m2 daily, to be administered over 30 minutes and to commence 1 hour after fludarabine infusion.


Locations(1)

Melbourne Health

Melbourne, Victoria, Australia

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NCT05005299


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