A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Part of paid clinical trials in Anaheim, California.

Sponsor
Incyte Corporation
Study ID
NCT02763319
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab (RTX) — DRUG
    Rituximab: Dose: 375 mg/m2 IV
  • Tafasitamab — DRUG
    Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)
  • Bendamustine (BEN) — DRUG

Study Details

The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

Key Dates

Start date
Nov 28, 2016
Status verified
Jul 2025
Primary completion
Jun 21, 2024
Completion
Jun 21, 2024

Study Design

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

Arms

  • Experimental: Tafasitamab and bendamustine
    Tafasitamab and bendamustine
  • Active Comparator: Rituximab and bendamustine
    Rituximab and bendamustine

Primary Outcome Measure

Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population [ Time Frame: up to 41.4 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
MorphoSys Research SiteAnaheimCalifornia92801-
MorphoSys Research SiteBakersfieldCalifornia93309-
Morphosys Research SiteBurbankCalifornia91505-
Morphosys Research SiteFresnoCalifornia93701-
MorphoSys Research SiteLos AngelesCalifornia90017-
MorphoSys Research SiteWhittierCalifornia90603-
MorphoSys Research SitePlainvilleConnecticut06062-
MorphoSys Research SiteSkokieIllinois60077-
MorphoSys Research SiteDetroitMichigan48202-
MorphoSys Research SiteRochesterMinnesota55905-
MorphoSys Research SiteHattiesburgMississippi39401-
Morphosys Research siteJacksonMississippi39126-
Morphosys Research SiteMorristownNew Jersey07960-
MorphoSys Research SiteNew YorkNew York10029-
MorphoSys Research SiteStony BrookNew York11794-
MorphoSys Research SiteOklahoma CityOklahoma73142-2015-
MorphoSys Research SiteKnoxvilleTennessee37909-
Morphosys Research SiteLubbockTexas79415-

Find similar trials in Anaheim, CA

By research site
MorphoSys Research Site· Anaheim, CAMorphoSys Research Site· Bakersfield, CAMorphosys Research Site· Burbank, CAMorphosys Research Site· Fresno, CAMorphoSys Research Site· Los Angeles, CAMorphoSys Research Site· Whittier, CA

Related Studies