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A Study of Cladribine, Ruxolitinib, and Venetoclax for Relapsed/Refractory T-cell Prolymphocytic Leukemia

This study is looking at a new combination of medicines – ruxolitinib, cladribine, and venetoclax – for people with T-cell Prolymphocytic Leukemia (T-PLL) that has come back or not responded to previous treatments. The main goal is to see how safe this combination is and what side effects it might cause. Researchers will also look at how well the treatment controls the disease, how long it takes to see a response, and how long that response lasts. You may be able to join if you are 18 or older and have T-PLL that is relapsed or refractory after prior treatment. The study plans to enroll 36 participants, but the current recruitment status is unclear.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07311746

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~36 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:RuxolitinibCladribineVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

T-cell Prolymphocytic Leukemia
Refractory T-Cell Prolymphocytic Leukemia

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T-Cell Prolymphocytic Leukemia

NCT07311746

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tapan Kadia, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Tapan Kadia, MD
[email protected]
(713) 563-3534
Email the study team

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Eligibility criteria

Inclusion

Patients must not have had T-PLL directed chemotherapy or antibody therapy for 7 days prior to starting ruxolitinib. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 3. Adequate organ function as defined below:
liver function (bilirubin \< 2mg/dL, AST and ALT \<3 x ULN - or ≤5 x ULN if related to leukemic involvement);
kidney function (estimated creatinine clearance \> 50);
known cardiac ejection fraction of ≥ 45% within the past 3 months prior to enrolling on the trial;
Platelet count of ≥ 30,000 (unless determined to be due to disease involvement). 4. ECOG performance status of ≤ 2. 5. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 6. Patients with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure. 8. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), IUD, Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 9. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ruxolitinib and venetoclax administration. 10. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0