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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

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE December 28, 2015
Results First Submitted Date  ICMJE December 13, 2019
Results First Posted Date  ICMJE January 30, 2020
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
Incidence and Severity of Adverse Events (AEs) [ Time Frame: 2 years ]
For details please see Section of Adverse Events Overview
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
Overall response rate (ORR) [ Time Frame: 2 years ]
Overall response rate (ORR) as defined as percentage of patients achieving a complete response (CR), a partial response (PR) or a partial response with lymphocytosis (PRL)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
  • Best Objective Response Rate (ORR) [ Time Frame: 2 years ]
    ORR = complete response [CR] + partial response [PR]; Local Evaluation
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Progression-free survival (PFS) [ Time Frame: 2 years ]
  • Overall survival (OS) [ Time Frame: up to 5 years ]
  • Time to progression (TTP) [ Time Frame: 2 years ]
  • Time to treatment failure (TTF) [ Time Frame: 2 years ]
  • Time to response (TTR) [ Time Frame: 2 years ]
  • Duration of response (DOR) [ Time Frame: 2 years ]
  • Lymph node response (LR) [ Time Frame: 2 years ]
  • Incidence and severity of adverse events (AEs) [ Time Frame: 2 years ]
  • Anti-MOR00208 antibody formation [ Time Frame: 2 years ]
  • Maximum Plasma Concentration (Cmax) of MOR00208 [ Time Frame: 2 years ]
    Pharmacokinetics of MOR00208
  • Patient-reported outcomes on the QLQ-C30 questionnaire [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2020)
Proportion of Patients With MRD-negativity [ Time Frame: 2 years ]
Proportion of patients who reached MRD-negativity in peripheral blood
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Intervention  ICMJE
  • 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
  • Drug: Venetoclax
    venetoclax dose: 400 mg once daily orally
    Other Name: Venclexta, Venclyxto; ABT-199
Study Arms  ICMJE
  • Experimental: Cohort A
    tafasitamab (MOR208) in combination with idelalisib
    Interventions:
    • Biological: Tafasitamab
    • Drug: Idelalisib
  • Experimental: Cohort B
    tafasitamab (MOR208) in combination with venetoclax
    Interventions:
    • Biological: Tafasitamab
    • Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 23, 2017)
24
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2015)
120
Estimated Study Completion Date  ICMJE August 2022
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Italy,   Poland,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT02639910
Other Study ID Numbers  ICMJE MOR208C205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MorphoSys AG
Study Sponsor  ICMJE MorphoSys AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Peter Kelemen, MD, PhD Clinical Development, MorphoSys AG
PRS Account MorphoSys AG
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP