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Study to Evaluate Safety and Preliminary Efficacy of MOR208 With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi (COSMOS)

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ClinicalTrials.gov Identifier: NCT02639910
Recruitment Status : Active, not recruiting
First Posted : December 28, 2015
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE December 28, 2015
Last Update Posted Date June 4, 2019
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: October 23, 2017)
Incidence and severity of adverse events (AEs) [ Time Frame: 2 years ]
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 Complete list of historical versions of study NCT02639910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2017)
  • Overall response rate (ORR) [ 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
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: February 6, 2017)
Proportion of patients with MRD-negativity [ Time Frame: 2 years ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Preliminary Efficacy of MOR208 With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi (COSMOS)
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 MOR00208 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.
Detailed Description

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of MOR00208 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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: MOR00208
    MOR208 dose: 12 mg/kg intravenous infusion
    Other Name: MOR208
  • 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: Two-Cohort
MOR00208 in combination with idelalisib or venetoclax
Interventions:
  • Biological: MOR00208
  • Drug: Idelalisib
  • 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
Study Completion Date  ICMJE Not Provided
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 Not Provided
PRS Account MorphoSys AG
Verification Date June 2019

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