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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 (COSMOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639910
Recruitment Status : Active, not recruiting
First Posted : December 28, 2015
Results First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Biological: Tafasitamab Drug: Idelalisib Drug: Venetoclax Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2016
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Venclexta, Venclyxto; ABT-199




Primary Outcome Measures :
  1. Incidence and Severity of Adverse Events (AEs) [ Time Frame: 2 years ]
    For details please see Section of Adverse Events Overview


Secondary Outcome Measures :
  1. Best Objective Response Rate (ORR) [ Time Frame: 2 years ]
    ORR = complete response [CR] + partial response [PR]; Local Evaluation

  2. 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

  3. 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)


Other Outcome Measures:
  1. Proportion of Patients With MRD-negativity [ Time Frame: 2 years ]
    Proportion of patients who reached MRD-negativity in peripheral blood



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639910


Locations
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United States, Florida
Clinical Study Site
Jacksonville, Florida, United States, 32204
United States, Minnesota
Clinical Study Site
Rochester, Minnesota, United States, 55905
United States, Ohio
Clinical Study Site
Columbus, Ohio, United States, 43210
Austria
Clinical Study Site
Graz, Austria, 8036
Clinical Study Site
Salzburg, Austria, 5020
Clinical Study Site
Wien, Austria, 1090
Germany
Clinical Study Site
Dresden, Germany, 1307
Clinical Study Site
Leipzig, Germany, 4103
Clinical Study Site
Muenchen, Germany, 80804
Italy
Clinical Study Site
Brescia, Italy, 25123
Clinical Study Site
Milano, Italy, 20162
Poland
Clinical Study Site
Gdansk, Poland, 80952
Clinical Study Site
Krakow, Poland, 30510
Clinical Study Site
Lublin, Poland, 85094
Clinical Study Site
Opole, Poland, 45372
United Kingdom
Clinical Study Site
Bournemouth, United Kingdom, BH7 7DW
Clinical Study Site
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
MorphoSys AG
Investigators
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Study Director: Peter Kelemen, MD, PhD Clinical Development, MorphoSys AG
  Study Documents (Full-Text)

Documents provided by MorphoSys AG:
Statistical Analysis Plan  [PDF] May 27, 2019
Study Protocol  [PDF] January 10, 2019

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Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02639910    
Other Study ID Numbers: MOR208C205
First Posted: December 28, 2015    Key Record Dates
Results First Posted: January 30, 2020
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MorphoSys AG:
CD19
MOR208
MOR00208
CLL
SLL
COSMOS
tafasitamab
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action