Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
MorphoSys AG
Study ID
NCT02639910
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tafasitamab — BIOLOGICAL
    tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
  • Idelalisib — DRUG
    idelalisib dose: 150 mg twice daily orally
  • Venetoclax — DRUG
    venetoclax dose: 400 mg once daily orally

Study Details

This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.

Key Dates

Start date
Nov 30, 2016
Status verified
Dec 2021
Primary completion
Nov 30, 2018
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Cohort A
    tafasitamab (MOR208) in combination with idelalisib
  • Experimental: Cohort B
    tafasitamab (MOR208) in combination with venetoclax

Primary Outcome Measure

Incidence and Severity of Adverse Events (AEs) [ Time Frame: 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Study SiteJacksonvilleFlorida32204-
Clinical Study SiteRochesterMinnesota55905-
Clinical Study SiteColumbusOhio43210-

Find similar trials in Jacksonville, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Clinical Study Site· Jacksonville, FLClinical Study Site· Rochester, MNClinical Study Site· Columbus, OH

Related Studies