Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03319901
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax is an inhibitor of Bcl-2. Bcl-2 is critical for keeping cancer cells alive. By inhibiting Bcl-2, venetoclax promotes cancer cell death.
  • Standard Chemotherapy — DRUG
    Standard treatment of chemotherapy is administered

Study Details

This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: * Venetoclax * Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine

Key Dates

Start date
Oct 30, 2017
Status verified
May 2026
Primary completion
Nov 25, 2025
Completion
May 30, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + Chemotherapy
    * Venetoclax is administered orally once daily for 21 days in each cycle * Standard Chemotherapy will be administered every 28 days

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
MD Anderson Cancer CenterHoustonTexas77030-
Intermountain LDS HospitalSalt Lake CityUtah84143-

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