Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cel… (NCT07311746) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia
United States36 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have histologically confirmed a diagnosis T-PLL that is relapsed or refractory after prior treatment.
✓. Age ≥ 18 years.
✓. Adequate organ function as defined below:
✓. ECOG performance status of ≤ 2.
✓. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
✓. 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.
✓. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
Exclusion criteria
✕. 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.
✕. 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.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
✕0. 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.
✕. Pregnant women are excluded from this study because the agent used has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
✕. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant or cardiac arrhythmia
✕. Patient with documented hypersensitivity to any of the components of the therapy program.
✕. Patients with known active, uncontrolled CNS leukemia will not be eligible.
✕. Patients with prior treatment with a JAK1, JAK2, or JAK3 inhibitor will not be eligible.