Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT02956382
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Refractory Follicular Lymphoma
  • Relapsed Follicular Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Ibrutinib is dispensed as a capsule.
  • Venetoclax — DRUG
    Venetoclax is dispensed as a tablet.

Study Details

This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.

Key Dates

Start date
Mar 1, 2017
Status verified
Jun 2025
Primary completion
May 23, 2023
Completion
Mar 7, 2024

Study Design

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

Arms

  • Experimental: Phase I - Dose Level 0
    Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long.
  • Experimental: Phase I - Dose Level 1
    Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long.
  • Experimental: Phase I - Dose Level 2
    Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg Each medication is taken daily. Treatment cycles are 28 days long.
  • Experimental: Phase I - Dose Level 3
    Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg Each medication is taken daily. Treatment cycles are 28 days long.
  • Experimental: Phase II Dose
    The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: Cycle 1 (28 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Washington D.C., DC

By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJSeattle Cancer Care Alliance· Seattle, WA

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