Clinical trial · Interventional
A Study Of The Selective PKC-β Inhibitor MS- 553
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
NCT03492125CI-TRIAL-00088388terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study is terminated due to major protocol revisions. A new study in CLL patients is planned.
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Lymphoma | Aggressive Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acalabrutinib | Drug | Acalabrutinib | ALIAS |
| MS-553 | Drug | — | UNRESOLVED |
| obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Phase I Dose Escalation Cohort A1 (MS-553 Monotherapy)
- description
- R/R CLL/SLL patients
- interventionNames
- Drug: MS-553
- type
- EXPERIMENTAL
- label
- Phase II Expansion Cohort A2 (MS-553 Monotherapy)
- description
- R/R CLL/SLL patients
- interventionNames
- Drug: MS-553
- type
- EXPERIMENTAL
- label
- Phase II Expansion Cohort A3 (MS-553 Monotherapy)
- description
- patients with aggressive lymphoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.