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This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.
Full description
This study includes a dose escalation phase and a dose expansion phase. In the dose escalation phase the MTD and/or RP2D of YY201 will be determined and in the dose expansion phase the anti-tumor efficacy of YY201 will be evaluated in patients with relapsed⁄refractory hematological malignancies. The two-phase study will assess the preliminary anti-tumor efficacy , safety, tolerability, and PK profile of YY201 .
Enrollment
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Volunteers
Inclusion criteria
The standard treatment failure (disease progression after treatment or treatment side effects not tolerance), or top treatment, or shall not apply to the current standard treatment for patients with:
In the dose-expansion phase, enrollment was limited to:
Regular check need to meet the following requirements:
For advanced solid tumors, adequate bone marrow, liver, and kidney function is required:
Blood system within 14 days (not received blood transfusions or hematopoietic stimulating factor treatment):
Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥75×10^9/L; Hemoglobin (Hb) ≥85g/L;
Liver function:
Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) ≤3×ULN; Spread to the liver or liver cancer patient: 5 or less x ULN; Aspartate aminotransferase (AST) or less 3 x ULN; Spread to the liver or liver cancer patient: 5 or less x ULN;
Renal function:
Creatinine (Cr) or less 1.5 x ULN; Creatinine clearance (Ccr) (calculated only when creatinine > 1.5× ULN) ≥50ml/min (calculated according to Cockcroft-Gault formula, see Annex 2 of the protocol);
Blood coagulation function:
Activated partial thromboplastin time (APTT) ≤1.5×ULN; International normalized ratio (INR) ≤1.5×ULN;
Urinary protein:
Urine routine /24 hours urine protein qualitative ≤1+; Or urine protein qualitative ≥2+, 24 hours urine protein < 1g;
For patients with PTCL, routine blood hemoglobin or 80 g/L, neutrophils acuity 1.0 x 10^9 / L, 75 x 10^9 or higher platelet/L (within 14 days before test without blood transfusion or the use of biological stimulating factor);
For patients with AML, white blood cell counts ≤25 ×10^9/L (Hydroxyurea was allowed but not for 3 days before administration of the trial drug);
Exclusion criteria
Within 4 weeks before delivery for the first time received chemotherapy, radiation therapy, biological therapy and endocrine therapy, immune therapy, such as antitumor drugs, with the exception of the following situations:
8.Unable to oral drug swallowing, or by the researchers determine the condition of the seriously affect the gastrointestinal tract absorption, including but not limited to, such as inflammatory bowel disease (crohn's disease and ulcerative colitis, for example), or malabsorption syndrome, or chronic diarrhea;
•Patients treated with fixed oral dose and/or topical corticosteroids for cutaneous GVHD may be enrolled with approval of the Sponsor.
Primary purpose
Allocation
Interventional model
Masking
96 participants in 1 patient group
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Central trial contact
Ye Guo
Data sourced from clinicaltrials.gov
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