An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in R… (NCT03580564) | Clinical Trial Compass
CompletedPhase 2
An Open, Multicenter Phase II Study to Evaluate the Safety and Efficacy of KL-A167 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma
China109 participantsStarted 2018-08-01
Plain-language summary
The study is to evaluate the efficacy of KL-A167 a in subjects with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years and older
* Histopathological confirmed classical Hodgkin's lymphoma
* Relapsed/refractory cHL include:subject with no response to or with progression after ASCT ;subject which failed failed second line and above chemtherapy;subject which didn't achieve PR after 2 cycles or didn't achieve CR after 4 cycles
* At least one measurable disease (long axis\>15 mm and short axis\>5 mm,or both axis\>10 mm)
* ECOG performance status of 0 or 12
* Subject must have adequate organ functions and meet requirements on laboratory values.:Count of Blood Cells: absolute neutrophil count (ANC) ≥ 1.0 × 109 / L; platelet count (PLT) ≥ 50 × 109 / L; hemoglobin content (HGB) ≥ 7.0 g / Dl; Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN,with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) and patients with hepatic metastases or Gilbert's syndrome (total bilirubin ≤ 3 × ULN)Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate(CCR)≥50 mL/min;International normalized ratio (INR) ≤ 1.5 x ULN ;Thyroid function: thyroid stimulating hormone (TSH) in normal range.
* Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy (including Chinese herbal medicine and Chinese patent medicine) used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of K…