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Phosphoinositide 3-Kinase (PI3K) Inhibitor

Ruxolitinib + Duvelisib for Lymphoma

Phase 1
Recruiting
Led By Alison Moskowitz, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status ≤2 as assessed in the ECOG grading system
Pathologically-confirmed mature T-cell lymphomas at the enrolling institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will study the safety of two drugs, ruxolitinib and duvelisib, in people with lymphoma who have relapsed or are refractory to other treatments.

Who is the study for?
Adults over 18 with certain types of T-cell lymphoma or leukemia, who've had at least one prior therapy (treatment-naive allowed for some conditions), can join this trial. They must be able to swallow pills, have a specific level of organ function, and not be pregnant or breastfeeding. Contraception is required during the study.Check my eligibility
What is being tested?
The trial tests Ruxolitinib at a fixed dose and Duvelisib at varying doses in people with relapsed/refractory NK-cell or T-cell lymphoma to determine their safety and effects.See study design
What are the potential side effects?
Potential side effects may include immune system suppression leading to infections, liver problems, digestive issues, fatigue, and possibly allergic reactions. The exact side effects will vary as different doses are being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My lymphoma is a type of T-cell lymphoma confirmed by tests.
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I am 18 years old or older.
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I have a specific type of T-cell lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment for MTD/optimal dose

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
23%
Pruritus
12%
Headache
9%
Diarrhoea
9%
Upper respiratory tract infection
8%
Fatigue
8%
Asthenia
8%
Thrombocytopenia
7%
Nausea
7%
Dizziness
7%
Night sweats
7%
Haematocrit increased
5%
Influenza
5%
Weight decreased
5%
Erythema
5%
Decreased appetite
5%
Leukocytosis
5%
Constipation
4%
Thrombocytosis
4%
Abdominal pain upper
4%
Arthralgia
4%
Hypertension
3%
Pain in extremity
3%
Oedema peripheral
3%
Dyspnoea
3%
Epistaxis
3%
Bronchitis
3%
Abdominal discomfort
3%
Tinnitus
3%
Nasopharyngitis
3%
Myalgia
3%
Dyspepsia
3%
Cough
1%
Anaemia
1%
Vertigo
1%
Depression
1%
Weight increased
1%
Haematoma
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Abdominal pain
1%
Neutropenia
1%
Muscle spasms
1%
Rectal haemorrhage
1%
Cellulitis
1%
Meningitis
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Acute myeloid leukaemia
1%
Bladder transitional cell carcinoma
1%
Breast cancer
1%
Myelofibrosis
1%
Extremity necrosis
1%
Abdominal distension
1%
Flatulence
1%
Vomiting
1%
Pyrexia
1%
Blood lactate dehydrogenase increased
1%
Gamma-glutamyltransferase increased
1%
Hyperuricaemia
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Cardiac failure
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
All Crossover Patients
Ruxolitinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ruxolitinib and DuvelisibExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
2016
Completed Phase 3
~750
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,551 Total Patients Enrolled
Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
546 Total Patients Enrolled

Media Library

Duvelisib (Phosphoinositide 3-Kinase (PI3K) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05010005 — Phase 1
Natural Killer Cell Lymphoma Research Study Groups: Ruxolitinib and Duvelisib
Natural Killer Cell Lymphoma Clinical Trial 2023: Duvelisib Highlights & Side Effects. Trial Name: NCT05010005 — Phase 1
Duvelisib (Phosphoinositide 3-Kinase (PI3K) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010005 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots available for this clinical trial?

"According to clinicaltrials.gov, this research project is currently recruiting participants and has been since August 12th 2021. The most recent update was recorded on November 14th 2022."

Answered by AI

Has Ruxolitinib been studied in any other medical experiments?

"Ruxolitinib has been in clinical research since 2002, with 106 completed trials. At present, 112 studies are seeking participants and most have sites located in Miami, Florida."

Answered by AI

What is the total participant count for this clinical experiment?

"Affirmative. Clinicaltrials.gov states that enrollment for this clinical trial is currently open, which was first posted on August 12th 2021 and modified most recently on November 14th 2022. 52 participants are needed across 9 different clinical sites."

Answered by AI

What maladies has Ruxolitinib been indicated to alleviate?

"Ruxolitinib is a common pharmaceutical for the treatment of lymphoma, follicular. Additionally, this drug can be employed to manage polycythemia vera, polycythemia and cases that are resistant or intolerant to hydroxyurea."

Answered by AI

Are there any outposts in North America conducting this clinical experiment?

"The recruitment of participants is being conducted in 9 different locations; these include the University of Miami (Data Collection Only) located in Miami, Memorial Sloan Kettering Nassau (Limited Protocol Activities) situated in Uniondale and Memorial Sloan Kettering Monmouth (Limited Protocol Activities) based in Middletown."

Answered by AI

Has the FDA sanctioned Ruxolitinib for therapeutic purposes?

"Ruxolitinib's risk profile is rated 1 on the Power scale due to limited data concerning its efficacy and safety, as it is in Phase 1 clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Memorial Sloan Kettering Westchester (Limited Protocol Activities): < 48 hours
Typically responds via
Phone Call
~19 spots leftby Aug 2025