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Bruton's Tyrosine Kinase (BTK) Inhibitor

itacitinib for Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically documented diagnosis of DLBCL.
Phase 1: any DLBCL subtype.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1573 days
Awards & highlights

Study Summary

This trial is testing a new combination therapy for people with DLBCL that has not responded to other treatments.

Eligible Conditions
  • Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1573 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1573 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
Phase 1: Number of Participants With Any Grade 3 or Higher TEAE
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
+1 more
Secondary outcome measures
Phase 1: ORR, Defined as the Percentage of Participants Achieving Either a CR or a PR, Per the Modified Lugano Classification for DLBCL
Phase 2: Durable Response Rate (DRR)
Phase 2: Duration of Response (DOR): Time From the First Overall Response Contributing to an Objective Response (CR or PR) to the Earlier of the Participant's Death and the First Overall Response of Progressive Disease, Per the Lugano Classification
+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 33 Patients • NCT02760485
50%
Fatigue
33%
Nausea
33%
Anaemia
33%
Asthenia
33%
Constipation
33%
Cough
33%
Diarrhoea
33%
Mental status changes
17%
Tremor
17%
Muscle tightness
17%
Pain in extremity
17%
Peripheral sensory neuropathy
17%
Wound infection pseudomonas
17%
Rash
17%
Skin infection
17%
Thrombocytopenia
17%
Vision blurred
17%
Pneumonia
17%
Pneumonia aspiration
17%
Tinnitus
17%
Blood cholesterol increased
17%
Cheilitis
17%
Chronic kidney disease
17%
Confusional state
17%
Decreased appetite
17%
Dyspepsia
17%
Dyspnoea
17%
Eye irritation
17%
Haematoma
17%
Tongue eruption
17%
Upper respiratory tract infection
17%
Injection site bruising
17%
Joint swelling
17%
Lymphocyte count decreased
17%
Palpitations
17%
Abdominal discomfort
17%
Abdominal pain upper
17%
Disorientation
17%
Dizziness
17%
Epistaxis
17%
Headache
17%
Hypertension
17%
Oropharyngeal pain
17%
Impetigo
17%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD
Phases 1 and 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD
Total

Trial Design

1Treatment groups
Experimental Treatment
Group I: itacitinib + ibrutinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
itacitinib
2016
Completed Phase 2
~340
ibrutinib
2012
Completed Phase 3
~1070

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
362 Previous Clinical Trials
55,050 Total Patients Enrolled
29 Trials studying Lymphoma
3,589 Patients Enrolled for Lymphoma
Fitzroy Dawkins, MDStudy DirectorIncyte Corporation
6 Previous Clinical Trials
535 Total Patients Enrolled
1 Trials studying Lymphoma
26 Patients Enrolled for Lymphoma
Peter Langmuir, MDStudy DirectorIncyte Corporation
10 Previous Clinical Trials
996 Total Patients Enrolled
2 Trials studying Lymphoma
58 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025