Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jacqueline Garcia, MD
Study ID
NCT05455294
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navitoclax — DRUG
    See Arm Description
  • Venetoclax — DRUG
    See Arm Description
  • Decitabine — DRUG
    See Arm Description

Study Details

The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies. The names of the drugs involved in this study are: * Venetoclax * Decitabine * Navitoclax

Key Dates

Start date
Jul 18, 2022
Status verified
Jan 2026
Primary completion
Apr 17, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0: Decitabine + Venetoclax + Navitoclax [AML and Non-AML]
    Dose Level 0 \[AML and Non-AML\] Decitabine \[intravenously (IV) preferred\] Venetoclax Cycle 1: ramp-up days 1-2 and days 3-14 absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing days 1-14 Navitoclax Cycle 1: dosing days 3-14; Cycle 2+: dosing on days 1-14 Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
  • Experimental: Dose Level 1: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]
    Dose Level 1 \[AML and Non-AML\] Decitabine \[intravenously (IV) preferred\] Cycle 1+: dosing on days 1-5 Venetoclax \[orally\] Cycle 1: ramp-up starting on day 1-2 then days 3-14 continued dosing in absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing days 1-14 Navitoclax \[orally\] Cycle 1: Dosing days 3-14 Cycle 2+: dosing on days 1-14 Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
  • Experimental: Dose Level 2: Venetoclax + Decitabine + Navitoclax [AML]
    Dose Level 2 \[AML\] Decitabine \[intravenously (IV) preferred\] Cycle 1+: dosing on days 1-5 Venetoclax \[orally\] Cycle 1: ramp-up on day 1-2, days 3-21 continued dosing in absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing on days 1-21 Navitoclax \[orally\] Cycle 1: dosing on days 3-14 Cycle 2+: dosing on days 1-14 Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
  • Experimental: Dose Level -1: Venetoclax + Decitabine + Navitoclax [Non-AML]
    Dose Level -1 \[Non-AML\] Decitabine \[intravenously (IV) preferred\] Cycle 1+:dosing \[intravenously (IV) preferred\] on days 1-3 Venetoclax \[orally\] Cycle 1: ramp-up of starting day 1-2 then days 3-7 continued dosing in absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing on days 1-7 Navitoclax \[orally\] Cycle 1: Dosing days 3-14 Cycle 2+: continued dosing on days 1-14 Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
  • Experimental: Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]
    RP2D \[AML and Non-AML\] Decitabine \[intravenously (IV) preferred\] To be determined based on dose escalation design. Venetoclax \[orally\] To be determined based on dose escalation design. Navitoclax \[orally\] To be determined based on dose escalation design. Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: The observation period for RP2D evaluation was the first 28 days (cycle 1) of treatment. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
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By specialty
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By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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