Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05157971
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • B Acute Lymphoblastic Leukemia
  • Ph-Like Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 54 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given SC, IV or IT
  • Daunorubicin Hydrochloride — DRUG
    Given IV
  • Mercaptopurine — DRUG
    Given PO
  • Methotrexate — DRUG
    Given IT
  • Pegaspargase — DRUG
    Given IM or IV
  • Prednisone — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with a pediatric-inspired chemotherapy regimen known as C10403 in treating patients with newly diagnosed B cell acute lymphoblastic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The C10403 regimen is composed of the chemotherapy drugs cytarabine, cyclophosphamide, daunorubicin, mercaptopurine, pegaspargase, vincristine, and methotrexate, all which work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It also consists of prednisone, which is an anti-inflammatory drug that lowers the body's immune response and is used with other drugs in the treatment of some types of some types of cancer. This study may help researchers learn if adding venetoclax to the pediatric-inspired C10403 regimen can be tolerated and help treat older patients.

Key Dates

Start date
Mar 17, 2022
Status verified
May 2026
Primary completion
Apr 12, 2027
Completion
Apr 12, 2027

Study Design

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

Arms

  • Experimental: Treatment (venetoclax, C10403 regimen)
    See Detailed Description

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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