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

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell
• Interventions: Biological: Tafasitamab; Drug: Idelalisib; Drug: Venetoclax

• Registration Number: NCT02639910
• Lead Sponsor: MorphoSys AG

Brief 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.

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Study Start: 2016-11
• Primary Completion: 2018-11
• Results First Submitted: 2019-12-13
• Results First Submitted QC: 2020-01-20
• Results First Posted: 2020-01-30
• Status Verified: 2021-12
• Study Completion: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A	Tafasitamab	tafasitamab (MOR208) in combination with idelalisib
Cohort A	Idelalisib	tafasitamab (MOR208) in combination with idelalisib
Cohort B	Tafasitamab	tafasitamab (MOR208) in combination with venetoclax
Cohort B	Venetoclax	tafasitamab (MOR208) in combination with venetoclax

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Adverse Events (AEs)	2 years	For details please see Section of Adverse Events Overview

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of MOR00208	At Cycle 3 Day 15	Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)
Best Objective Response Rate (ORR)	2 years	ORR = complete response \[CR\] + partial response \[PR\]; Local Evaluation
Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation	2 years	Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation

Trial Locations

Locations (1)

Clinical Study Site; 🇬🇧 Leeds, United Kingdom