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Trial record 5 of 6 for:    MOR00208

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 : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Biological: MOR00208 Drug: Idelalisib Drug: Venetoclax Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : November 2016
Estimated Primary Completion Date : September 2019


Arm Intervention/treatment
Experimental: Two-Cohort
MOR00208 in combination with idelalisib or venetoclax
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




Primary Outcome Measures :
  1. Incidence and severity of adverse events (AEs) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 2 years ]
  2. Anti-MOR00208 antibody formation [ Time Frame: 2 years ]
  3. Maximum Plasma Concentration (Cmax) of MOR00208 [ Time Frame: 2 years ]
    Pharmacokinetics of MOR00208


Other Outcome Measures:
  1. Proportion of patients with MRD-negativity [ Time Frame: 2 years ]


Information from the National Library of Medicine

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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
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

Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT02639910     History of Changes
Other Study ID Numbers: MOR208C205
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MorphoSys AG:
CD19
MOR208
MOR00208
CLL
SLL
COSMOS

Additional relevant MeSH terms:
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