A Study Of The Selective PKC-β Inhibitor MS- 553
Megadott ok: The study is terminated due to major protocol revisions. A new study in CLL patients is planned.
Key facts
- Where
- Ann Arbor, Columbus, Houston, New York és Salt Lake City, Egyesült ÁllamokSee the 5 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- University Of Michigan Comprehensive Cancer CenterAnn Arbor, Egyesült ÁllamokNo longer taking part
- The Ohio State University James Comprehensive Cancer CenterColumbus, Egyesült ÁllamokNo longer taking part
- MD Anderson Cancer Center, Department of LeukemiaHouston, Egyesült ÁllamokNo longer taking part
- Columbia University / Herbert Irving Comprehensive Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
- Huntsman Cancer InstituteSalt Lake City, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- MingSight Pharmaceuticals, Inc
- Trial code
- NCT03492125
- Record updated
- 2025. április 10.
- Original description
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 LymphomaRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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); Active and uncontrolled autoimmune cytopenia(s); 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.