Trial Outcomes & Findings for Itacitinib + Everolimus in Hodgkin Lymphoma (NCT NCT03697408)

Last Updated: 2025-05-30

Results Overview

Evaluate the efficacy of itacitinib in combination with everolimus in subjects with relapsed or refractory cHL as demonstrated by complete response (CR) rate, defined as the percentage of subjects achieving CR as their best response.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

2 Years

Results posted on

2025-05-30

Participant Flow

Study: 23 evaluable subjects. Phase I: 6 to 15 subjects enrolled (with at least 6 subjects treated at the recommended Phase II dose (RP2D)). The itacitinib starting dose is 300 mg once daily (QD). Depending on tolerability, the itacitinib dose could be increased to 400 mg QD or decreased to 200 mg QD. The everolimus dose will remain 5 mg QD for each cohort. Phase II: Additional subjects will receive the RP2D of itacitinib with everolimus as determined in Phase I.

Participant milestones

Participant milestones
Measure	Cohort 1 (Starting Dose) Itacitinib 300 mg once daily (QD) in combination with everolimus 5 mg QD	Cohort 2 Itacitinib 400 mg once daily (QD) in combination with everolimus 5 mg QD
Phase I (Dose Finding) STARTED	3	6
Phase I (Dose Finding) COMPLETED	3	6
Phase I (Dose Finding) NOT COMPLETED	0	0
Phase II (Treatment) STARTED	3	20
Phase II (Treatment) COMPLETED	3	20
Phase II (Treatment) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Itacitinib + Everolimus in Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (Starting Dose) n=3 Participants Itacitinib 300 mg once daily (QD) in combination with everolimus 5 mg QD.	Cohort -1 Itacitinib 200 mg once daily (QD) in combination with everolimus 5 mg QD.	Cohort 2 n=20 Participants Itacitinib 400 mg once daily (QD) in combination with everolimus 5 mg QD.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	20 Participants n=5 Participants	22 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	14 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	19 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	0 Participants n=7 Participants	16 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Efficacy will be assessed by CR rate, defined as the percentage of subjects achieving Complete Response (CR) as their best response

Outcome measures

Outcome measures
Measure	Cohort 1 (Starting Dose) n=3 Participants Itacitinib 300 mg once daily (QD) in combination with everolimus 5 mg QD.	Cohort -1 Itacitinib 200 mg once daily (QD) in combination with everolimus 5 mg QD.	Cohort 2 n=20 Participants Itacitinib 400 mg once daily (QD) in combination with everolimus 5 mg QD.
Phase II: Efficacy of Itacitinib in Combination With Everolimus	33.3 percentage of subjects achieving CR Interval 10.2 to 90.5	—	25 percentage of subjects achieving CR Interval 8.66 to 49.1

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1 (Starting Dose)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Cohort -1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2

Serious events: 6 serious events

Other events: 20 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 (Starting Dose) n=3 participants at risk Itacitinib 300 mg once daily (QD) in combination with everolimus 5 mg QD.	Cohort -1 Itacitinib 200 mg once daily (QD) in combination with everolimus 5 mg QD.	Cohort 2 n=20 participants at risk Itacitinib 400 mg once daily (QD) in combination with everolimus 5 mg QD.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
General disorders Fever	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	10.0% 2/20 • Number of events 2 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Infections and infestations Sepsis	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Infections and infestations Shingles	33.3% 1/3 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	0.00% 0/20 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Infections and infestations Upper respiratory infection	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Renal and urinary disorders Renal colic	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Vascular disorders Hypotension	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).
Vascular disorders Thromboembolic event	0.00% 0/3 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	— 0/0 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).	5.0% 1/20 • Number of events 1 • Adverse event data is collected from the time of informed consent until End-of-Treatment visit - 14 months Cohorts into which subjects with relapsed/refractory classical Hodgkin lymphoma (cHL) were enrolled. No subjects were enrolled into Cohort -1 (starting dose of itacitinib 200 mg in combination with everolimus 5 mg).

Other adverse events

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 215-662-4484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place