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About
This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.
Enrollment
Sex
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Inclusion criteria
Exclusion criteria
Biopsy-proven and pathologically confirmed current or past transformation to Richter's syndrome.
Patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
Patients who have received any of the following treatments within 14 days prior to the first dose:
Major surgery;
Glucocorticoids (at a dose equal to or greater than 20 mg/day prednisone or equivalent), unless used by inhalation, topical or intraarticular route, or unless necessary for premedication before and after iodinated contrast dye. After discussion with the Sponsor, steroid therapy at high doses for an extended period may be allowed under the following circumstances:
Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which a washout of 24 hours prior to the first dose is required.
Toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ Grade 1 (except for alopecia); atrial fibrillation from prior treatment with BTK inhibitors did not restore to ≤ Grade 2.
Central nervous system (CNS) leukemia or lymphoma, including a history of asymptomatic, previously treated CNS disease.
Primary purpose
Allocation
Interventional model
Masking
13 participants in 4 patient groups
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Central trial contact
Ling Yang
Data sourced from clinicaltrials.gov
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