A Study Of The Selective PKC-β Inhibitor MS- 553

Stopped early · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Aggressive Lymphoma

In brief

A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Key facts

Study ID

NCT03492125

Run by

MingSight Pharmaceuticals, Inc

People needed

60

Starts

2018-05-25

Expected to finish

2023-11-28

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following criteria:
• Age 18 years or older
• Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
• History of histologically documented CLL or SLL that meets IWCLL diagnostic criteria according to the 2008 guidelines, and
• Indication for treatment as defined by the 2008 IWCLL guidelines, or the need for disease reduction prior to allogeneic transplantation

You may not qualify if…

• Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study:
• Current or past transformation of CLL/SLL to prolymphocytic leukemia (PLL), non-Hodgkin lymphoma, or Hodgkin lymphoma aggressive lymphoma outlined in the inclusion criteria for the optional cohort.
• Active and uncontrolled autoimmune cytopenia(s)
• Any of the following prior therapies within 14 days prior to cycle 1, day 1:
• Major surgery
• 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
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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