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New treatment option for T-cell Prolymphocytic Leukemia
Official title Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia
ClinicalTrials.gov ID: NCT07311746
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for t-cell prolymphocytic leukemia.
Also referred to as Jakafi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically confirmed a diagnosis T-PLL that is relapsed or refractory after prior treatment.
- Age ≥ 18 years.
- Patients must not have had T-PLL directed chemotherapy or antibody therapy for 7 days prior to starting ruxolitinib. However, patients with rapidly...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or how well it works assessment...
- Adequate organ function as defined below:
You likely can't join if
- Pregnant women are excluded from this study because the agent used has the potential for teratogenic or abortifacient effects. Because there is a...
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III...
- 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.
- Men and women of childbearing potential who do not practice contraception.
See the full eligibility criteria
- Patients must have histologically confirmed a diagnosis T-PLL that is relapsed or refractory after prior treatment.
- Age ≥ 18 years.
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial.
- 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).
- 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. The effects of ruxolutinib on the developing human fetus are unknown. For this reason...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Men and women of childbearing potential who do not practice contraception.
- Known history of active HIV infection (HIV 1/2 antibodies).
- Active HBV or HCV infection that requires treatment or at risk for HBV reactivation. Hepatitis B virus DNA and HCV RNA must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface...
- Patients who are receiving any other investigational agents.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.