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Trial record 8 of 16 for:    tqb2450

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800706
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Safety and Effectiveness Drug: TQB2450 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TQB2450 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.




Primary Outcome Measures :
  1. Overall Response Rate(ORR) [ Time Frame: Up to 96 weeks ]
    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


Secondary Outcome Measures :
  1. Complete Response (CR) [ Time Frame: Up to 96 weeks ]
    Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800706


Contacts
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Contact: Yuan Kai Shi 13701251865 syuankai@cicams.ac.cn

Locations
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China
No.17, panjiayuan nanli, chaoyang district, Beijing Recruiting
Beijing, China, 100021
Contact: YuanKai Shi         
Principal Investigator: YuanKai Shi         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03800706    
Other Study ID Numbers: TQB2450-II-01
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases