Status:
RECRUITING
Pilot Study of Reduced Venetoclax Exposure
Lead Sponsor:
Northwell Health
Conditions:
Acute Myeloid Leukemia in Remission
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Pilot Study of Reduced Venetoclax Exposure
Detailed Description
A pilot single-arm clinical trial is proposed to assess the primary objective: the tolerability of 14-day Venetoclax cycles in acute myeloid leukemia (AML) patients who have achieved remission and are...
Eligibility Criteria
Inclusion
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to take oral medication and be willing to adhere to the study regimen
- Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
- 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
- Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
- Achieving morphological CR/CRi by bone marrow biopsy with \<5% blasts within 3 cycles. See Appendix 2 for definitions.
- Consent to be obtained within 10 days (+/- 3 days) of bone marrow biopsy report showing morphological remission. C1D1 of trial to be initiated within 10 days (+/- 7 days) of bone marrow biopsy report showing morphological remission.
- ECOG 0-3
- Intensive treatment ineligible; transplant ineligible or refusal of transplant
- Patient must be able to understand and sign informed consent and additional study documents
- On C1D1 of trial, patient must have count recovery with ANC \>1000, platelets \> 50, Hemoglobin \> 7.7 and without transfusion support for 7 days.
- No growth factor (G-CSF) use in 14 days prior to C1 D1 of trial.
Exclusion
- Treatment with another investigational drug
- Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.
- On concomitant targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor.
- Subject has received treatment prior to induction with the following:
- i. Prior hypomethylating agent or BCL-2 inhibitor for either AML or MDS other than for induction prior to enrollment.
- ii. Prior CAR-T cell therapy. iii. Experimental or investigational drug therapy for 14 days prior to study entry leukemia-directed therapies.
- Subject has:
- i. Acute promyelocytic leukemia (APL) with t(15;17). ii. Presence of t(9;22) given the potential indication for concurrent tyrosine kinase therapy.
- iii. Known active CNS involvement with AML.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT07163793
Start Date
October 7 2024
End Date
October 1 2028
Last Update
November 20 2025
Active Locations (1)
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1
Zuckerberg Cancer Center
New Hyde Park, New York, United States, 11042