Itacitinib + Everolimus in Hodgkin Lymphoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT03697408
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Classical Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    A JAK 1 selective small molecule inhibitor
  • Everolimus — DRUG
    A mammalian target of rapamycin (mTOR) inhibitor

Study Details

This is an open-label, single-group, Phase I/II study of itacitinib in combination with everolimus in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL).

Key Dates

Start date
Feb 11, 2019
Status verified
May 2025
Primary completion
May 20, 2024
Completion
Jun 30, 2027

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort -1
    Itacitinib 200 mg once daily (QD) in combination with everolimus 5 mg QD
  • Experimental: Cohort 1 (starting dose)
    Itacitinib 300 mg once daily (QD) in combination with everolimus 5 mg QD
  • Experimental: Cohort 2
    Itacitinib 400 mg once daily (QD) in combination with everolimus 5 mg QD

Primary Outcome Measure

Phase II: Efficacy of Itacitinib in Combination With Everolimus [ Time Frame: 2 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

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