Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07311746
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Refractory T-Cell Prolymphocytic Leukemia
  • T-cell Prolymphocytic Leukemia

Eligibility Criteria

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

Interventions

Study Details

The goal of this clinical research study is to learn if the combination of ruxolitinib with cladribine and venetoclax can help to control the disease in patients with R/R T-PLL.

Key Dates

Start date
Jun 1, 2026
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2031

Study Design

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

Arms

  • Experimental: SingleArm: Phase 1b/II - ESC/EXP Treatment with Ruxolitinib + Cladribine + Venetoclax
    Participants will receive treatment on an inpatient basis for the first cycle and can be administered on an outpatient basis for the subsequent cycles.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Tapan Kadia, MD
[email protected]
713-563-3534
Tapan Kadia, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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