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Phosphoinositide 3-Kinase (PI3K) Inhibitor
Ruxolitinib + Duvelisib for Lymphoma
Phase 1
Waitlist Available
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
Pathologically-confirmed mature T-cell lymphomas at the enrolling institution
Permitted histologies include Stage ≥Ib CTCL, systemic anaplastic large cell lymphoma, T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, aggressive NK-cell leukemia, adult T-cell leukemia/lymphoma, extranodal NK/T-cell lymphoma, nasal type, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, hepatosplenic T cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, primary cutaneous gamma/delta T-cell lymphoma, primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T cell lymphoma, follicular T-cell lymphoma, nodal peripheral T-cell lymphoma with T follicular helper phenotype
Must not have
Receiving therapy for another primary malignancy
Prior surgery or gastrointestinal condition affecting drug absorption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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 belowSelect...
My lymphoma is a type of T-cell lymphoma confirmed by tests.
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I have a specific type of T-cell lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for another type of cancer.
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I have had surgery or a condition that affects how drugs are absorbed in my body.
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I stopped taking duvelisib or ruxolitinib because of side effects.
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I do not have any severe or uncontrolled health issues.
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I had a stem cell transplant less than 6 months ago or I need medicine for graft-versus-host disease.
Select...
My cancer has spread to my brain or its coverings.
Select...
I am not taking high doses of steroids or certain medications.
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I have a history of liver disease or I currently abuse alcohol.
Select...
I am not taking any strong medications that affect liver enzymes.
Select...
I cannot or do not want to take medication to prevent infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 • NCT0203803633%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Bronchitis
3%
Paraesthesia
3%
Blood creatine phosphokinase increased
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Vertigo
2%
Localised infection
2%
Ureterolithiasis
2%
Night sweats
2%
Urethral stenosis
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Peripheral artery thrombosis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
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. 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
2016
Completed Phase 3
~760
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,702 Total Patients Enrolled
Alison Moskowitz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
10 Previous Clinical Trials
546 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- To participate in this clinical trial, you must have specific types of lymphoma or leukemia that have relapsed after at least one prior therapy. You must also have certain laboratory test results within normal ranges and be able to swallow pills. Women who are of reproductive age must have a negative pregnancy test and agree to use birth control during the study and for three months after the last dose of study drug.I am currently being treated for another type of cancer.My lymphoma is a type of T-cell lymphoma confirmed by tests.I have a specific type of T-cell lymphoma.I can take care of myself but might not be able to do heavy physical work.I have had surgery or a condition that affects how drugs are absorbed in my body.I can swallow pills.I haven't had cancer treatment for TCL in the last 14 days.I stopped taking duvelisib or ruxolitinib because of side effects.I have not received a live vaccine in the last 6 weeks.I do not have any severe or uncontrolled health issues.I had a stem cell transplant less than 6 months ago or I need medicine for graft-versus-host disease.I have been treated for tuberculosis within the last 2 years.My cancer has spread to my brain or its coverings.I am not taking high doses of steroids or certain medications.I am 18 years old or older.I have a history of liver disease or I currently abuse alcohol.I am not taking any strong medications that affect liver enzymes.I cannot or do not want to take medication to prevent infections.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib and Duvelisib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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