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

December 10, 2021 updated by: MorphoSys AG

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Clinical Study Site
      • Salzburg, Austria, 5020
        • Clinical Study Site
      • Wien, Austria, 1090
        • Clinical Study Site
  • Germany
      • Dresden, Germany, 1307
        • Clinical Study Site
      • Leipzig, Germany, 4103
        • Clinical Study Site
      • Muenchen, Germany, 80804
        • Clinical Study Site
  • Italy
      • Brescia, Italy, 25123
        • Clinical Study Site
      • Milano, Italy, 20162
        • Clinical Study Site
  • Poland
      • Gdansk, Poland, 80952
        • Clinical Study Site
      • Krakow, Poland, 30510
        • Clinical Study Site
      • Lublin, Poland, 85094
        • Clinical Study Site
      • Opole, Poland, 45372
        • Clinical Study Site
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Clinical Study Site
      • Leeds, United Kingdom, LS9 7TF
        • Clinical Study Site
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Clinical Study Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Clinical Study Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major inclusion criteria

Diagnosis/Trial Population

  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):

    • history of diagnosis of CLL or SLL that meets IWCLL diagnostic criteria
    • histologically confirmed diagnosis of SLL by lymph node biopsy
    • indication for treatment as defined by the IWCLL guidelines

  • Patients must have both of the following:

    • relapsed or refractory disease while receiving a BTKi therapy or intolerance of such therapy
    • single-agent or combination therapy with a BTKi for at least one month must be the patient's most recent prior anticancer therapy
  • ECOG performance status of 0 to 2
  • Patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery

Laboratory Values

• Patients must meet adequate bone marrow function and adequate hepatic and renal function

Other Inclusion Criteria

• Females of childbearing potential must use a highly effective method of contraception

Major exclusion criteria

Diagnosis

• Patients who have:

  • non-Hodgkin's lymphomas other than CLL/SLL
  • transformed CLL/SLL or Richter's syndrome
  • active and uncontrolled autoimmune cytopenia

Previous and Current Treatment

  • Patients who have received treatment with a BTK inhibitor within 5 days prior to Day 1 dosing

  • Patients who have, within 14 days prior to D1 dosing:

    • not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
    • systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease
    • received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
tafasitamab (MOR208) in combination with idelalisib
Biological: Tafasitamab
tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
Other Names:
  • MOR208
  • MOR00208
Drug: Idelalisib
idelalisib dose: 150 mg twice daily orally
Other Names:
  • Zydelig; GS-1101 or CAL-101
Experimental: Cohort B
tafasitamab (MOR208) in combination with venetoclax
Biological: Tafasitamab
tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
Other Names:
  • MOR208
  • MOR00208
Drug: Venetoclax
venetoclax dose: 400 mg once daily orally
Other Names:
  • Venclexta, Venclyxto; ABT-199

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Severity of Adverse Events (AEs)
Time Frame: 2 years
For details please see Section of Adverse Events Overview
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Objective Response Rate (ORR)
Time Frame: 2 years
ORR = complete response [CR] + partial response [PR]; Local Evaluation
2 years
Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation
Time Frame: 2 years
Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation
2 years
Maximum Plasma Concentration (Cmax) of MOR00208
Time Frame: 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)
At Cycle 3 Day 15

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With MRD-negativity
Time Frame: 2 years
Proportion of patients who reached MRD-negativity in peripheral blood
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MorphoSys AG

Investigators

  • Study Director: Anke Muth, Clinical Development, MorphoSys AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR208C205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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