T-cell Prolymphocytic LeukemiaPhase 1/2NCT07311746
Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia
A Phase 1/2 study testing Ruxolitinib, Cladribine and Venetoclax in people with T-cell Prolymphocytic Leukemia and Refractory T-Cell Prolymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Prolymphocytic Leukemia, Refractory T-Cell Prolymphocytic Leukemia
- What is being tested?
- Ruxolitinib, Cladribine and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2026to 31 Jan 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
- 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);
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- 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 and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- 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 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.
- 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.
Who cannot join
- 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.
- Men and women of childbearing potential who do not practice contraception.
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- 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 antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
- Patients who are receiving any other investigational agents.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Tapan Kadia, MD, 713-563-3534, tkadia@mdanderson.org
Tapan Kadia, MD
About this study
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.
Read the detailed description
Primary Objective:
- To evaluate the safety and tolerability of Ruxolitinib in combination with Cladribine and Venetoclax in patients with R/R T-PLL.
Secondary Objectives:
- To evaluate the EFS in patients with T-PLL treated with Ruxolitinib in combination with Cladribine and Venetoclax.
- To evaluate response (CR, including CRi, or PR) of Ruxolitinib in combination with Cladribine and Venetoclax in patients with T-PLL.
- To assess the time to response, response duration, and OS in patients with T-PLL treated with Ruxolitinib in combination with Cladribine and Venetoclax.
Exploratory Objective:
- To explore correlation of genomic profile, baseline patient and disease characteristics, and response to BCL-2 inhibition.
- Being tested
- Ruxolitinib, Cladribine, Venetoclax
- Medical subject headings
- Leukemia, Prolymphocytic, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi
Given orally
CladribineDrug
Also called Mavenclad
Given by injection
VenetoclaxDrug
Also called Venclexta
Taken by mouth
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Arm: Phase 1b/II - ESC/EXP | Experimental | 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. Receives: Drug: Ruxolitinib; Drug: Cladribine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start28 Apr 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Prolymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tapan Kadia, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311746
- Sponsor's protocol ID
- 2025-1464
- Other IDs
- NCI-2025-09671
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT07311746
- Acronym / sponsor ID
- 2025-1464
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
- To evaluate the safety and tolerability of Ruxolitinib in combination with Cladribine and Venetoclax in patients with R/R T-PLL.
Secondary Objectives:
- To evaluate the EFS in patients with T-PLL treated with Ruxolitinib in combination with Cladribine and Venetoclax.
- To evaluate response (CR, including CRi, or PR) of Ruxolitinib in combination with Cladribine and Venetoclax in patients with T-PLL.
- To assess the time to response, response duration, and OS in patients with T-PLL treated with Ruxolitinib in combination with Cladribine and Venetoclax.
Exploratory Objective:
- To explore correlation of genomic profile, baseline patient and disease characteristics, and response to BCL-2 inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Arm: Phase 1b/II - ESC/EXP | Experimental | Drug: Ruxolitinib, Drug: Cladribine, Drug: VenetoclaxStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: JakafiGiven orally | Drug | Phase 1b Arm: Phase 1b/II - ESC/EXP |
| CladribineAlso: MavencladGiven by injection | Drug | Phase 1b Arm: Phase 1b/II - ESC/EXP |
| VenetoclaxAlso: VenclextaTaken by mouth | Drug | Phase 1b Arm: Phase 1b/II - ESC/EXP |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tapan Kadia, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ruxolitinib, Cladribine and Venetoclax in people with T-cell Prolymphocytic Leukemia and Refractory T-Cell Prolymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tapan Kadia, MD ((713) 563-3534, tkadia@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.