A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05386576
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    During Induction I, for patients on Dose Level 1, venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28. For patients on Dose Level 01, venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28. During Induction II, venetoclax will be administered at either 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-14 and 29-42.

Study Details

The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.

Key Dates

Start date
Jun 16, 2022
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

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

Arms

  • Experimental: Venetoclax in Combination With Chemotherapy
    All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP.

Primary Outcome Measure

proportion of patients who have a Dose Limiting Toxicities [ Time Frame: up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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