CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Tafasitamab +2 morebiological
Likely dose
Tafasitamab 12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02639910
NCT02639910Phase 2Completed
CompareCT.gov

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

MorphoSys AG·interventional·Posted Dec 28, 2015·Updated Dec 20, 2021

In Brief

A Phase 2 clinical trial evaluating Tafasitamab, Idelalisib, and 1 other intervention for Leukemia, Lymphocytic, Chronic, B-Cell and 2 related conditions. Completed, enrolled 24 participants across 17 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesAustria, Germany, Italy, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 28, 2015
Enrollment StartNov 1, 2016
Primary CompletionNov 1, 2018
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.5 years ago

Interventions

Tafasitamabbiological

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

Idelalisibdrug

idelalisib dose: 150 mg twice daily orally

Venetoclaxdrug

venetoclax dose: 400 mg once daily orally