Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Seagen Inc.
Study ID
NCT02592876
Phase
PHASE2
Status
Terminated

Conditions

  • Follicular Lymphoma, Grade 3b
  • Lymphoma, B-cell
  • Lymphoma, Follicular, Grade 3b
  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

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

Interventions

  • denintuzumab mafodotin — DRUG
    Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.
  • rituximab — DRUG
    375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles
  • ifosfamide — DRUG
    5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
  • carboplatin — DRUG
    AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles
  • etoposide — DRUG
    100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles

Study Details

The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.

Key Dates

Start date
Oct 31, 2015
Status verified
Apr 2019
Primary completion
Apr 20, 2018
Completion
Apr 20, 2018

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 19A+RICE
    Denintuzumab mafodotin plus rituximab, ifosfamide, carboplatin, and etoposide
  • Active Comparator: RICE
    Rituximab, ifosfamide, carboplatin, and etoposide

Primary Outcome Measure

Complete Remission Rate Per Independent Review Facility [ Time Frame: Up to 4 months ]

Locations (29)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
City of Hope National Medical CenterDuarteCalifornia91010-3000-
Scripps Mercy Cancer CenterSan DiegoCalifornia92103-
Colorado Blood Cancer InstituteDenverColorado80218-
Yale Cancer CenterNew HavenConnecticut06520-
Shands Cancer Center / University of FloridaGainesvilleFlorida32610-
University of MiamiMiamiFlorida33136-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Winship Cancer Institute / Emory University School of MedicineAtlantaGeorgia30322-
Rush University Medical CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-1470-
Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywoodIllinois60153-
University of Kansas Cancer CenterWestwoodKansasUnited States-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of MinnesotaMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
UNC Lineberger Comprehensive Cancer Center / University of North CarolinaChapel HillNorth Carolina27599-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
MD Anderson Cancer Center / University of TexasHoustonTexas77030-4095-
San Antonio Military Medical CenterSan AntonioTexas78234-
University of VirginiaCharlottesvilleVirginia22908-
Seattle Cancer Care Alliance / University of WashingtonSeattleWashington98109-1023-
Carbone Cancer Center / University of WisconsinMadisonWisconsinUnited States-
Medical College of Wisconsin (Milwaukee)MilwaukeeWisconsin53226-

Find similar trials in Little Rock, AR

By research site
University of Arkansas for Medical Sciences· Little Rock, ARCity of Hope National Medical Center· Duarte, CAScripps Mercy Cancer Center· San Diego, CAColorado Blood Cancer Institute· Denver, COYale Cancer Center· New Haven, CTShands Cancer Center / University of Florida· Gainesville, FL

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