Description:
A Phase I Dose-Escalation Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
A Phase I Dose-Escalation Study Of The Selective PKC-Β Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
MS-533 | high dose |
Name | Type | Description | Interventions |
---|---|---|---|
low dose | Experimental | MS-533 |
|
mid low dose | Experimental | MS-533 |
|
mid high dose | Experimental | MS-533 |
|
high dose | Experimental | MS-533 |
|
Inclusion Criteria: To be eligible for inclusion in the primary escalation and expansion cohort 1 in this study, patients must meet all of the following 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 Exclusion Criteria: Patients who meet any of the following criteria are not eligible for the primary escalation and expansion cohorts of this study: 1. 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. 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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | The primary objective of this study is to evaluate the safety of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy. |
Time Frame: | Assessments for DLT and TEAE will occur during cycle 1. The primary endpoint will be the rate of DLT and TEAE requiring study drug discontinuation in the first 28 days |
Safety Issue: | |
Description: | The primary endpoint of this study is the incidence rate of dose-limiting toxicities and treatment-emergent adverse events requiring study drug discontinuation |
Measure: | To evaluate the clinical activity (i.e. the overall response rate (ORR) of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at least one prior therapy. |
Time Frame: | Screening, post cycle 3 and 6 cycles (each cycle is 28 days) |
Safety Issue: | |
Description: | This will be assessed according to the International Workshop on Chronic Lymphocytic Leukemia Response Criteria with modifications for treatment-related lymphocytosis. |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | MingSight Pharmaceuticals, Inc. |
June 2, 2021