A Study of Ruxolitinib and Duvelisib in People With Lymphoma
Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas
1 other identifier
interventional
70
1 country
9
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2021
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2021
CompletedStudy Start
First participant enrolled
August 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 9, 2026
April 1, 2026
6 years
August 12, 2021
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment for MTD/optimal dose
3 subjects will be enrolled and followed for eight weeks of safety assessments. If no DLT is observed after all three subjects have been observed for eight weeks, a second cohort of 3 subjects will be enrolled at the next highest dose level. Cohorts will continue to be enrolled and observed until one subject experiences a DLT or the maximum dose level is reached with 0 or 1/6 DLTs.
1 year
Secondary Outcomes (2)
Estimate the disease control rate
6 months
Estimate the disease control rate (R+D in patients with T-PLL and TFH lymphomas)
6 months
Study Arms (1)
Ruxolitinib and Duvelisib
EXPERIMENTALRuxolitinib 20mg BID plus Duvelisib 25mg, 50mg, or 75mg BID. Patients will be instructed to take duvelisib and ruxolitinib by mouth every 12 hours, the same time each day, +/- 2 hours. Duvelisib and ruxolitinib will be provided via the institutional investigational pharmacy. The researchers will utilize a dose-escalation standard 3+3 design in which we evaluate 3 doses of duvelisib (25mg BID, 50mg BID, and 75mg BID) in combination with ruxolitinib 20mg BID. A minus-1 dose level of duvelisib (15mg BID) can be used if de-escalation is needed. The cohort expansion phase will have two treatment groups JAK/STAT activation or mutation present or JAK/STAT activation or mutation absent or unknown. Upon discussion with PI, the treating physician may increase dose up to 20 mg of ruxotlinib and/or 25 mg of duvelisib when deemed clinically favorable. T-prolymphocytic leukemia (T-PLL) and T-follicular helper (TFH) lymphoma expansion: Further expansion for patients with T-PLL and TFH lymphomas.
Interventions
Eligibility Criteria
You may qualify if:
- 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 systemic therapies. In order to ensure balanced enrollment for patients with systemic T-cell lymphoma and CTCL, a maximum of 15 CTCL patients will be enrolled in expansion cohort.
- ii) Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin.
- iii) T-cell prolymphocytic leukemia (treatment naïve permitted)
- For the following histologies, patients are required to have received at least 1 prior therapy (dose escalation and expansion):
- iv) T-cell large granular lymphocytic leukemia
- v) Aggressive NK-cell leukemia
- vi) Adult T-cell leukemia/lymphoma
- vii) Extranodal NK/T- cell lymphoma, nasal type
- viii) Enteropathy-associated T-cell lymphoma
- ix) Monomorphic epitheliotropic intestinal t-cell lymphoma
- x) Hepatosplenic T cell lymphoma
- xi) Subcutaneous panniculitis-like T-cell lymphoma
- xii) Primary cutaneous anaplastic large cell lymphoma
- +30 more criteria
You may not qualify 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 allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment...
- d) Prior use of duvelisib or ruxolitinib if either agent was discontinued due to toxicity.
- e) Previous systemic anti-cancer therapy for TCL within 14 days of initiating study drug
- a. Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator.
- i. Patients receiving treatment with single agent ruxolitinib or duvelisib may be allowed to enroll onto the study without a washout period
- b. Systemic corticosteroids must be tapered to 20mg/day or less prednisone (or equivalent) upon start of investigational treatment.
- c. Topical steroids for CTCL is permitted on study.
- f) Ongoing use of immunosuppressant medications, including corticosteroids greater than 20mg of prednisone or equivalent at the time of enrollment
- g) History of chronic liver disease, veno-occlusive disease, or current alcohol abuse
- h) Administration of a live vaccine within 6 weeks of first dose of study drug.
- i) Prior surgery or gastrointestinal condition that may adversely affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
- j) Patients with HIV infection if they meet either of the below criteria:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Miami (Data Collection Only)
Miami, Florida, 33125, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison Moskowitz, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2021
First Posted
August 18, 2021
Study Start
August 12, 2021
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.