Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02077166
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Refractory Diffuse Large B-Cell Lymphoma
  • Relapsed Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

Study Details

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.

Key Dates

Start date
Mar 13, 2014
Status verified
Jan 2022
Primary completion
Dec 17, 2020
Completion
Dec 17, 2020

Study Design

Enrollment
138 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1)
    Ibrutinib 560 mg administered orally (PO) once daily (QD) beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered intravenously (IV) on Day 1 of each 28-day cycle for 6 cycles.
  • Experimental: Phase 1b: Enrolled at Lenalidomide Dose 10 mg (Dose Level -1)
    De-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 10 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
  • Experimental: Phase 1b: Enrolled at Lenalidomide Dose 15 mg (Dose Level 1+)
    Re-escalation cohort: Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 15 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
  • Experimental: Phase 1b: Enrolled at Lenalidomide Dose 20 mg (Dose Level 2)
    Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
  • Experimental: Phase 1b: Enrolled at Lenalidomide Dose 25 mg (Dose Level 3)
    Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
  • Experimental: Phase 2: Enrolled at Lenalidomide Dose 20 mg
    Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 20 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.
  • Experimental: Phase 2: Enrolled at Lenalidomide Dose 25 mg
    Ibrutinib 560 mg administered PO QD beginning Cycle 1 Day 1 until disease progression or unacceptable toxicity. Lenalidomide 25 mg administered PO QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity. Rituximab 375 mg/m\^2 administered IV on Day 1 of each 28-day cycle for 6 cycles.

Primary Outcome Measure

Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) [ Time Frame: Estimated median time on study in Phase 1b was 59.6 months. ]

Locations (22)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
Banner MD Anderson Cancer CenterGilbertArizona85234-
Cedar Sinai Medical CenterLos AngelesCalifornia90048-
UCLA Medical CenterLos AngelesCalifornia90095-
University of FloridaGainesvilleFlorida32610-
Rush University Medical CenterChicagoIllinois60612-
University of IowaIowa CityIowa52242-
Tulane Medical CenterNew OrleansLouisiana70112-
Karmanos Cancer InstituteDetroitMichigan48201-
Comprehensive Cancer Center of NevadaLas VegasNevada89169-
Hackensack University Medical CenterHackensackNew Jersey07601-
Summit Medical GroupMorristownNew Jersey07960-
Weill Cornell Medical CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of Cincinnati Health Barrett CenterCincinnatiOhio45267-
Mid-Ohio Oncology/ HematologyColumbusOhio43219-
University of TN Medical CenterKnoxvilleTennessee37920-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
Baylor Charles Sammons Cancer CenterDallasTexas75246-
The University of Texas, MD Anderson Cancer CenterHoustonTexas77030-
Medical Oncology Associates, PSSpokaneWashington99208-
Northwest Medical Specialities, PLLCTacomaWashington98405-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZCedar Sinai Medical Center· Los Angeles, CAUCLA Medical Center· Los Angeles, CAUniversity of Florida· Gainesville, FLRush University Medical Center· Chicago, IL

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