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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

No Placebo-Only Group

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.

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.

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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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:

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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.

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My cancer has spread to my brain or its coverings.

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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.

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I am not taking any strong medications that affect liver enzymes.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment for MTD/optimal dose

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

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

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Peripheral artery thrombosis

Vertigo

Acute pulmonary oedema

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

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. 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

~1170