Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment Naïve AML

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03709758
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax blocks an important pathway that promotes cell survival in tumor cells that overexpress BCL-2, so venetoclax causes cells to die
  • Daunorubicin — DRUG
    Chemotherapy is most effective at killing cells that are rapidly dividing.
  • Cytarabine — DRUG
    Chemotherapy is most effective at killing cells that are rapidly dividing.

Study Details

This research study is studying the combination of venetoclax and chemotherapy as a possible treatment for acute myelogenous leukemia (AML). The drugs involved in this study are: * Venetoclax * Daunorubicin * Cytarabine

Key Dates

Start date
Oct 17, 2018
Status verified
Jan 2026
Primary completion
Feb 23, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax+Daunorubicin+Cytarabine
    * Venetoclax administered orally on days 1 to 11 daily * Daunorubicin administered intravenously on days 2-4 * Cytarabine administered on days 2-8 by continuous IV infusion

Primary Outcome Measure

Maximum Tolerated Dose (Induction) [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-

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