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
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

First listed
Dec 31, 2025
Start date
Apr 28, 2026
Status verified
Jul 2026
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: Phase 1b Arm: Phase 1b/II - ESC/EXP
    Study Arms 1. Phase 1b Arm (Dose Escalation / Expansion) - Experimental Cycle 1 Ruxolitinib: oral, twice daily starting Day 1 (dose assigned at enrollment). Cladribine: IV, Days 4-8 (5 days). Venetoclax: oral, Days 4-28; dose ramp-up daily until target dose reached on Day 6. Cycles 2+ Ruxolitinib: oral, twice daily, Days 1-28. Venetoclax: oral, once daily, Days 1-28. Cladribine: IV, Days 1-5. Remission rule: Cladribine may be discontinued once remission is achieved. 2. Phase II Arm (Dose Expansion at MTD) - Experimental Cycle 1 Ruxolitinib: oral, twice daily at MTD starting Day 1. Cladribine: IV, Days 4-8. Venetoclax: oral, Days 4-28 with ramp-up to target dose by Day 6. Cycles 2+ Identical to Phase 1b: ruxolitinib (BID), venetoclax (QD), cladribine (Days 1-5). Remission rule: Cladribine may be discontinued once remission is achieved.

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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