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New treatment option for T-cell Lymphomas
Official title A Study of Ruxolitinib and Duvelisib in People With Lymphoma
ClinicalTrials.gov ID: NCT05010005
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, being studied as a potential treatment for t-cell lymphomas.
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
- This study will test the safety of ruxolitinib, given at one dose that does not change, and duvelisib, given at different doses, to find out what effects, if any, the study treatment has on people with relapsed or refractory NK-cell or T-cell lymphoma. This study has three parts: dose escalation (Part 1), dose expansion (Part 2), and TFH/T-PLL cohort expansion (Part 3).
- Phase 1: an early, usually small safety study
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
- a) Pathologically-confirmed mature T-cell lymphomas at the enrolling institution. Permitted histologies include (for dose escalation and expansion)...
- Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
- Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
- Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN i...
- Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL)...
You likely can't join if
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
- Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression. a. Prior...
- people with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction [PCR] test)...
- Such agents must be discontinued at least 2 weeks prior to study intervention
- Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions n) Receipt of...
See the full eligibility criteria
- a) Pathologically-confirmed mature T-cell lymphomas at the enrolling institution. Permitted histologies include (for dose escalation and expansion): i) Stage ≥Ib CTCL, which has relapsed or progressed after at least two...
- Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
- Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
- Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN i. Creatinine clearance should be calculated per institutional standard d...
- Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed).
- Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
- c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN i. Creatinine clearance should be calculated per institutional standard d...
- Revised International Working Group Classification for systemic lymphoma19
- Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
- mSWAT (Modified Severity Weighted Assessment Tool) \>0 g) Ability to swallow pills h) Women of reproductive potential\ must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test within 14...
- A woman of reproductive potential is a sexually-mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had...
- The effects of duvelisib on conception, pregnancy, and lactation are unknown. Since duvelisib has not been evaluated in pregnant or nursing women, the treatment of pregnant women or women of childbearing potential who...
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
- Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression. a. Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI...
- people with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction [PCR] test) to be enrolled, and must receive hepatitis B prophylaxis until at...
- Such agents must be discontinued at least 2 weeks prior to study intervention
- Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions n) Receipt of treatment for tuberculosis within 2 years prior to enrollment o)...
- Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
- Early-stage cutaneous basal cell and squamous cell carcinomas are permissible
- Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator. p) Known central nervous system or meningeal...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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 Miami, Florida, United States; Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 3 more location(s). 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.