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Not yet recruiting NCT06979076

A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL/SLL

Phase I / Phase II Interventional CLL (Chronic Lymphocytic Leukemia) SLL (Small Lymphocytic Lymphoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MS-553, DS1, MS-553, DS2.
Who it may be relevant to
Registry conditions: CLL (Chronic Lymphocytic Leukemia), SLL (Small Lymphocytic Lymphoma). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Overview

A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions

  • Drug MS-553, DS1
    Oral, Dose Schedule 1
  • Drug MS-553, DS2
    Oral, Dose Schedule 2

Primary outcome measures

  • The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older.
  • Diagnosis of CLL or SLL:
  • History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and
  • Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.-

Exclusion criteria

  • Current transformation of CLL/SLL non-Hodgkin lymphoma or Hodgkin lymphoma.
  • Active and uncontrolled autoimmune cytopenia(s).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06979076 · MS-553-201-CLL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗