Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

Part of paid clinical trials in Duarte, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT04801797
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cytarabine — DRUG
    Intravenous infusion
  • Idarubicin — DRUG
    Intravenous infusion
  • Daunorubicin — DRUG
    Intravenous infusion
  • Liposomal daunorubicin and cytarabine — DRUG
    Intravenous infusion
  • Venetoclax — DRUG
    Orally by mouth
  • Azacitidine — DRUG
    Intravenous infusion

Study Details

This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: * Venetoclax and azacitidine (investigational combination) * Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)

Key Dates

Start date
May 20, 2021
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard of Care (Conventional Induction)
    Randomized participants will receive cytarabine and idarubicin \[or daunorubicin) per standard of care as follows: Induction: cytarabine on days 1-7 and idarubicin (or daunorubicin) on days 1-3 of induction. Second Induction (if needed): Cytarabine on days 1-5 and idarubicin (or daunorubicin) on days 1-2 of re-induction. Consolidation (if needed): If \< 60 years, cytarabine days 1,3,5 of consolidation cycles, and if ≥60 years, cytarabine days 1-5 of consolidation cycles Those with secondary or therapy-related AML can receive liposomal daunorubicin and cytarabine (Vyxeos) per standard of care as follows: Induction: Liposomal daunorubicin and cytarabine (Vyxeos) on Days 1,3, 5 of induction. Second Induction (if needed): Liposomal daunorubicin and cytarabine (Vyxeos) on days 1,3 of re-induction Consolidation (if needed): liposomal daunorubicin and cytarabine (Vyxeos) on days 1,3 of consolidation cycles
  • Experimental: Investigational (Venetoclax and Azacitidine)
    Participants will receive azacitidine on days 1-7 and venetoclax daily for up to (3) three 28-day study cycles and evaluated for response or benefit. If benefit/response is achieved, azacitidine on days 1-7 and venetoclax on days 1-28 (or less if deemed necessary per protocol) will be given in repeating 28-day cycles until benefit/response is no longer achieved or until patient proceeds to transplantation.

Primary Outcome Measure

Event free survival [ Time Frame: From the time from randomization to time for up to 3 years, per protocol. ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Stanford Cancer CenterPalo AltoCalifornia94304-
University of California - DavisSacramentoCalifornia95817-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204-
Ohio State University Medical CenterColumbusOhio43210-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAStanford Cancer Center· Palo Alto, CAUniversity of California - Davis· Sacramento, CABeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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