A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Safety and Effectiveness Clinical Trial

Official title:

A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800706
• Other study ID #: TQB2450-II-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yuan Kai Shi
• Phone: 13701251865
• Email: syuankai[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of TQB2450 in patients of non-hodgkin lymphoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject has voluntarily agreed to participate by giving written informed consent.;

2. Histopathological confirmed classical Hodgkin's lymphoma;

3. 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

4. Age ranged from 18 to 75 years;

5. At least one measurable disease ;

6. Patients must have ECOG performance status of 0-2;

7. 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 Criteria:

• 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;

Related Conditions & MeSH terms

• Hodgkin Disease
• Safety and Effectiveness

Intervention

Drug:
• TQB2450
TQB2450 is injectived (IV) every-3-weeks (Q3W) and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent, the longest use time of experimental drugs is 96 weeks.

Locations

Country	Name	City	State
China	No.17, panjiayuan nanli, chaoyang district, Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate(ORR)	Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification	Up to 96 weeks
Secondary	Complete Response (CR)	Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).	Up to 96 weeks