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Pilot Study of Reduced Venetoclax Exposure | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Pilot Study of Reduced Venetoclax Exposure

A Pilot Study of Reduced Venetoclax Exposure in Patients With Acute Myeloid Leukemia in Complete Remission

NCT07163793•Northwell Health

View on ClinicalTrials.gov

Summary

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 ineligible for intensive treatment. Participants in the study will transition to a maintenance regimen that reduces the Venetoclax dosage to 14 days per cycle while continuing the hypomethylating agent (HMA) used during induction. Treatment cycles will occur every 28 days. Participants will continue treatment on study until experiencing a grade 4 cytopenic event lasting more than 7 days, an adverse event requiring regimen modification, relapse, or death. Our primary hypothesis posits that AML patients receiving Venetoclax for 14 days per cycle will exhibit improved treatment tolerability with a reduced rate of grade 4 cytopenia compared to historical data from the VIALE A trial.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Stated willingness to comply with all study procedures and availability for the duration of the study
•2. Ability to take oral medication and be willing to adhere to the study regimen
•3. Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
•1. 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
•2. Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
•4. Achieving morphological CR/CRi by bone marrow biopsy with \<5% blasts within 3 cycles. See Appendix 2 for definitions.
•5. 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.
•6. ECOG 0-3
•7. Intensive treatment ineligible; transplant ineligible or refusal of transplant
•8. Patient must be able to understand and sign informed consent and additional study documents
+2 more criteria

Exclusion Criteria

•1. Treatment with another investigational drug
•2. Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.
•3. On concomitant targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor.
•4. 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.
•5. 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.

Locations (1)

Zuckerberg Cancer Center

New Hyde Park, New York, United States

Key Dates

Start Date

October 7, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2028

Last Updated

November 20, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia in Remission

Interventions

Azacitidine

DRUG

Decitabine

DRUG

Venetoclax

DRUG

Contacts

Heme Referral Team

CONTACT

(516) 734-8896 ci-hematology@northwell.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Study of Reduced Venetoclax Exposure

Inclusion Criteria

Exclusion Criteria

MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

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Total Marrow and Lymphoid Irradiation, Fludarabine, and Melphalan Before Donor Stem Cell Transplant in Treating Participants With High-Risk Acute Leukemia or Myelodysplastic Syndrome

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD