Status:
UNKNOWN
A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Safety and Effectiveness
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma
Eligibility Criteria
Inclusion
- Subject has voluntarily agreed to participate by giving written informed consent.;
- Histopathological confirmed classical Hodgkin's lymphoma;
- Relapsed/refractory cHL include：a)subject with relapse and progression after salvage chemotherapy followed by autologous stem cell transplantation(ASCT); b) subject with no ASCT: The first-line chemotherapy must be systemic multi-drug combination chemotherapy and subsequent chemotherapy requires at least one first-line chemotherapy must be systemic multi-drug combination chemotherapy; subject which is refractory didn't achieve PR after 2 cycles or didn't achieve CR after
- Age ranged from 18 to 75 years;
- At least one measurable disease ;
- Patients must have ECOG performance status of 0-2;
- Subject must have adequate organ functions ：Count of Blood Cells:hemoglobin content(HB)≥80g/L; absolute neutrophil count (ANC) ≥ 1.0 × 10\^9 / L; platelet count (PLT) ≥ 75 × 10\^9 / L;; Biochemical examination: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), with the exception of patients with hepatic metastases and Gilbert's syndrome(TBIL≤3×ULN） ; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN，with the exception of patients with hepatic metastases (ALT and AST ≤ 5 × ULN) , serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance rate（CCR）≥50 mL/min；Serum amylase and lipase ≤ 1.5 x ULN Blood coagulation function:International standardized ratio(INR)≤1.5×ULN、Activation partial thrombin time(APTT)≤1.5×ULN、Prothrombin time≤1.5×ULN；Doppler ultrasound evaluation：Left ventricular ejection fraction（LVEF)≥50%×MLN;
Exclusion
- 1、Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma； 2、 Prior exposure to any anti-PD-1, anti-PD-L1 ， anti-CTLA-4 antibody or CAR-T cell treatment(Any other antibody that has been applied to a T cell synergistic stimulus or checkpoint pathway); 3、Need to therapy with other anticancer during the study; 4、Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03800706
Start Date
March 25 2019
End Date
December 31 2021
Last Update
October 12 2020
Active Locations (1)
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1
No.17, panjiayuan nanli, chaoyang district, Beijing
Beijing, China, 100021