B-cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Study of YY-20394 Given Orally to Patients With Relapsed or Refractory B Cell Hematologic Malignancies
Protocol YY-20394-001 is a phase I open-label, first in human, dose escalation study to assess the tolerability, pharmacokinetics (PK) and efficacy of YY-20394 in patients with relapse or refractory B cell malignant hematological tumor.
This is a two-part study comprised of a dose escalation part and a dose expansion part.
In the dose escalation part single patient cohorts will be dosed until a single related
toxicity of Grade ≥ 3 or a Dose Limiting Toxicity (DLT) is observed. If this occurs, the
study will switch to a conventional oncology 3+3 design (3 patients per dose cohort, with the
potential to add an additional 3 patients if toxicity is observed) and escalation will
continue until the maximum tolerated dose (MTD) is reached and a recommended Phase II (RP2D)
dose is determined. Once the MTD is established a separate dose expansion part will enroll up
total additional 12 patients at the RP2D.
In this clinical trial, YY-20394 is given orally once daily. A treatment cycle is defined as
28 days. YY-20394 was given until disease progression, unacceptable toxicity, or withdrawal
from the study. The protocol was initiated with a single-patient cohort, treated with oral
YY-20394 20 mg once daily (QD). Subsequent cohorts used a 3+3 design and evaluated doses of
40-320mg QD. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Efficacy was assessed
according to IWG-NHL and CLL consensus response criteria.
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