A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05010005
Phase
PHASE1
Status
Recruiting
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Conditions

  • NK-Cell Lymphomas
  • T-cell Large Granular Lymphocyte Leukemia
  • T-cell Lymphomas
  • T-cell Prolymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib 20mg BID
  • Duvelisib — DRUG
    Duvelisib 25mg, 50mg, or 75mg BID

Study Details

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).

Key Dates

Start date
Aug 12, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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. T-prolymphocytic leukemia (T-PLL) and T-follicular helper (TFH) lymphoma expansion: Further expansion for patients with T-PLL and TFH lymphomas.

Primary Outcome Measure

Assessment for MTD/optimal dose [ Time Frame: 1 year ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Miami (Data Collection Only)MiamiFlorida33125-
Dana Farber Cancer InstituteBostonMassachusetts02115
Eric Jacobsen, MD
617-582-9086
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Alison Moskowitz, MD
646-608-3726
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Alison Moskowitz, MD
646-608-3726
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Alison Moskowitz, MD
646-608-3726
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Alison Moskowitz, MD
646-608-3726
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Alison Moskowitz, MD
646-608-3726
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alison Moskowitz, MD
646-608-3726
Steven Horwitz, MD
646-608-3725
Alison Moskowitz, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Alison Moskowitz, MD
646-608-3726

Find similar trials in Miami, FL

By research site
University of Miami (Data Collection Only)· Miami, FLDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Commack (Limited Protocol Activities)· Commack, NY

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