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

NCT02639910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-20

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Tafasitamab

tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion

DRUG

Idelalisib

idelalisib dose: 150 mg twice daily orally

DRUG

Venetoclax

venetoclax dose: 400 mg once daily orally

Sponsors & Collaborators

  • MorphoSys AG

    lead INDUSTRY

Principal Investigators

  • Anke Muth · Clinical Development, MorphoSys AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-11-30
Completion
2021-12-31

Countries

  • United States
  • Austria
  • Germany
  • Italy
  • Poland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639910 on ClinicalTrials.gov