Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL

Part of paid clinical trials in Tucson, Arizona.

Sponsor
MorphoSys AG
Study ID
NCT04134936
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tafasitamab — DRUG
    Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
  • Tafasitamab plus lenalidomide — DRUG
    Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP

Study Details

This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

Key Dates

Start date
Dec 11, 2019
Status verified
Oct 2024
Primary completion
Feb 11, 2021
Completion
Aug 10, 2022

Study Design

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

Arms

  • Experimental: Arm A
    Tafasitamab in addition to R-CHOP
  • Experimental: Arm B
    Tafasitamab plus lenalidomide in addition to R-CHOP

Primary Outcome Measure

Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 6 months approximately ]

Locations (23)

FacilityCityStateZIPSite coordinators
MorphoSys Research SiteTucsonArizona85711-
MorphoSys Research SiteAnaheimCalifornia92801-
MorphoSys Research SiteDuarteCalifornia91010-
MorphoSys Research SiteEncinitasCalifornia92024-
MorphoSys Research SiteAuroraColorado80012-
MorphoSys Research SiteNew HavenConnecticut06520-
MorphoSys Research SiteWashington D.C.District of Columbia20037-
MorphoSys Research SiteUrbanaIllinois61801-
MorphoSys Research SiteLouisvilleKentucky40207-
MorphoSys Research SiteCovingtonLouisiana70433-
MorphoSys Research SiteRockvilleMaryland20850-
MorphoSys Research SiteAnn ArborMichigan48109-5864-
MorphoSys Research SiteRochesterMinnesota55905-
MorphoSys Research SiteCincinnatiOhio45236-
MorphoSys Research SiteClevelandOhio44106-
MorphoSys Research SiteEugeneOregon97401-
MorphoSys Research SiteCharlestonSouth Carolina29425-
MorphoSys Research SiteAustinTexas78705-
MorphoSys Research SiteDallasTexas75246-
MorphoSys Research SiteHoustonTexas77030-
MorphoSys Research SiteSan AntonioTexas78240-
MorphoSys Research SiteTylerTexas75702-
MorphoSys Research SiteVancouverWashington98684-

Find similar trials in Tucson, AZ

By research site
MorphoSys Research Site· Tucson, AZMorphoSys Research Site· Anaheim, CAMorphoSys Research Site· Duarte, CAMorphoSys Research Site· Encinitas, CAMorphoSys Research Site· Aurora, COMorphoSys Research Site· New Haven, CT

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