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RecruitingLast updated: 2 February 2024

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

Clinical summary

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.

Conditions

This trial is treating patients with acute leukaemia, myelodysplastic syndrome, chronic lymphocytic leukaemia, B-cell non-Hodgkin lymphoma, and plasma cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18 - 75

Phase

I

Trial Acronym

VICTORY

More information

Trial Identifiers

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Trial sponsor

Melbourne Health

Scientific Title

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

Eligibility

Inclusion

Patients are eligible for inclusion if all of the following criteria are met:

  • Age ≥ 18 years
  • Planned to undergo alloSCT 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:

    1. Calculated creatinine clearance >50ml/min as measured by Cockroft Gault formula
    2. AST and ALT ≤ 3.0 x ULN
    3. Bilirubin ≤ 1.5 x ULN (except patients with Gilbert's Syndrome)
  • Able to tolerate oral medications
  • Disease status at the time of transplantation as follows:

    1. Acute leukaemia in complete morphologic remission
    2. Myelodysplastic syndrome with less than 10% bone marrow blasts
    3. CLL in complete remission (CR), partial response (PR) or PR with lymphocytosis
    4. NHL in CR or PR
    5. 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

Exclusion

Patients will be excluded from this study if any of the following criteria are met:

  • Moderate or high risk of tumour lysis syndrome prior to conditioning for allogeneic transplantation, defined as:

    1. For CLL: Diameter of any lymph node or tumour mass >5cm OR absolute lymphocyte count≥25x10^9/L
    2. For NHL: Diameter of any lymph node or tumour mass >5cm
  • 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:

    1. For CLL: Diameter of any lymph node or tumour mass <5cm OR absolute lymphocyte count≤25x10^9/L
    2. For NHL: Diameter of any lymph node or tumour mass <5cm
  • Reticulin fibrosis of the marrow of grade MF 2-3
  • Prior allogeneic stem cell transplantation
  • Haemopoietic cell transplantation - comorbidity index (HCT-CI) score > 5
  • Any currently active malignancy other than the primary indication for alloSCT (except localized basal cell carcinoma or squamous cell carcinoma of the skin)
  • Uncontrolled systemic infection
  • Known malabsorption syndrome
  • Has received within 7 days prior to the first dose of venetoclax CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin and St John's wort
  • Has received within 7 days prior to the first dose of venetoclax CYP3A4 inhibitors
  • Known positivity to HIV
  • Significant physical or psychiatric comorbid illness that in the investigator's opinion would impair the patient's ability to participate in the study.

Inclusion

  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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