Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2018-05-25
2023-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
R/R CLL/SLL patients
MS-553
Oral, multiple dose levels
Phase II Expansion Cohort A2 (MS-553 Monotherapy)
R/R CLL/SLL patients
MS-553
Oral recommended phase 2 dose of MS-553
Phase II Expansion Cohort A3 (MS-553 Monotherapy)
patients with aggressive lymphoma
MS-553
Oral recommended phase 2 dose of MS-553
Phase I Combination Dose Escalation Cohort B1
BTK inhibitor naïve CLL/SLL patients
MS-553
Oral, multiple dose levels
acalabrutinib
Oral
Phase II Expansion Cohort B2
BTK inhibitor naïve CLL/SLL patients
MS-553
Oral recommended phase 2 dose of MS-553
acalabrutinib
Oral
Phase II Expansion Cohort B3
BTK inhibitor naïve CLL/SLL patients with certain gene mutations
MS-553
Oral recommended phase 2 dose of MS-553
acalabrutinib
Oral
Phase I Combination Dose Escalation Cohort C1
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553
Oral, multiple dose levels
venetoclax
Oral
Rituximab
IV
obinutuzumab
IV
Experimental: Phase II Expansion Cohort C2
Bcl-2 inhibitor naïve CLL/SLL patients
MS-553
Oral recommended phase 2 dose of MS-553
venetoclax
Oral
Rituximab
IV
obinutuzumab
IV
Interventions
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MS-553
Oral, multiple dose levels
MS-553
Oral recommended phase 2 dose of MS-553
acalabrutinib
Oral
venetoclax
Oral
Rituximab
IV
obinutuzumab
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age 18 years or older
2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
1. History of histologically documented CLL or SLL that meets IWCLL diagnostic criteria according to the 2008 guidelines, and
2. Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for disease reduction prior to allogeneic transplantation
2. Active and uncontrolled autoimmune cytopenia(s)
3. Any of the following prior therapies within 14 days prior to cycle 1, day 1:
1. Major surgery
2. Corticosteroids greater than 20 mg / day prednisone (or equivalent), unless used by inhalation or topical route, or unless necessary for premedication before iodinated contrast dye, or for autoimmune hemolytic anemia
3. Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which no wash out is required (but must be stopped before cycle 1 day 1)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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MingSight Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, United States
The Ohio State University, James Comprehensive Cancer Center
Columbus, Ohio, United States
MD Anderson Cancer Center, Department of Leukemia
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MS-553-103
Identifier Type: -
Identifier Source: org_study_id
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