Trials / Completed
CompletedNCT02639910
Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi
A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined With Idelalisib or Venetoclax in Patients With Relapsed or Refractory CLL/SLL Previously Treated With Bruton's Tyrosine Kinase (BTK) Inhibitor
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- MorphoSys AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (MOR208) combined with idelalisib or venetoclax. The study will include safety run-in phase for each cohort with an evaluation of the safety data by an Independent Data Monitoring Committee. An optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., CD19 expression) after tafasitamab treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-11-01
- Completion
- 2021-12-01
- First posted
- 2015-12-28
- Last updated
- 2021-12-20
- Results posted
- 2020-01-30
Locations
17 sites across 6 countries: United States, Austria, Germany, Italy, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT02639910. Inclusion in this directory is not an endorsement.