A Study of Ruxolitinib and Duvelisib in People With Lymphoma
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ClinicalTrials.gov Identifier: NCT05010005 |
Recruitment Status :
Active, not recruiting
First Posted : August 18, 2021
Last Update Posted : April 4, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 12, 2021 | ||||
First Posted Date ICMJE | August 18, 2021 | ||||
Last Update Posted Date | April 4, 2024 | ||||
Actual Study Start Date ICMJE | August 12, 2021 | ||||
Estimated Primary Completion Date | August 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Assessment for MTD/optimal dose [ Time Frame: 1 year ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Ruxolitinib and Duvelisib in People With Lymphoma | ||||
Official Title ICMJE | Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: This phase I study includes a dose escalation phase and a dose expansion phase. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Ruxolitinib and Duvelisib
Ruxolitinib 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
49 | ||||
Original Estimated Enrollment ICMJE |
52 | ||||
Estimated Study Completion Date ICMJE | August 2025 | ||||
Estimated Primary Completion Date | August 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Permitted histologies include: 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: 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 xiii) Primary cutaneous gamma/delta T-cell lymphoma xiv) Primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma xv) Peripheral T-cell lymphoma, not otherwise specified xvi) Angioimmunoblastic T cell lymphoma xvii) Follicular T-cell lymphoma xviii) Nodal peripheral T-cell lymphoma wih T follicular helper phenotype b) Age ≥18 years at time of enrollment c) Performance status, as assessed in the ECOG grading system, ≤2 d) Laboratory criteria. Laboratory criteria i) For dose escalation phase:
ii) For dose expansion phase:
e) Measurable disease, defined by at least one of the following: °Revised International Working Group Classification for systemic lymphoma19 °Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
Exclusion Criteria:
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
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: i. detectable viral load ii. undetectable viral load with CD4 count <200 or not taking anti-retroviral medications. k) Patients with chronic hepatitis B or C as defined by positive hepatitis B or C serology:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05010005 | ||||
Other Study ID Numbers ICMJE | 21-176 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |