A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06561074
Phase
PHASE2
Status
Recruiting
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Conditions

  • T-Cell Lymphoblastic Lymphoma
  • T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
1 Month - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    Given by vein
  • Venetoclax — DRUG
    Given by mouth
  • Calaspargase pegol-mknl — DRUG
    Given by vein

Study Details

To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied.

Key Dates

Start date
Sep 25, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

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

Arms

  • Experimental: Treatment w/Calaspargase pegol-mknl + Decitabine + Venetoclax

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77090
David McCall, MD
[email protected]
713-792-6604
David McCall, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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