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Diffuse Large B-cell LymphomaPhase 3NCT03777085

Study of TQB2303 in Patients With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)

A Phase 3 study testing TQB2303 and Rituximab in people with Diffuse Large B-cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 31 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Purpose of This Study is to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics between TQB2303 and Rituximab in Combination With CHOP in Previously Untreated Patients with Diffuse Large B-cell Lymphoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
TQB2303 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
31 sitesChina
Study dates
10 Jan 2019to 30 Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated CD20-positive DLBCL patients confirmed by histopathology or cytology.
  • 18 years to 75 years; Male or female patients.
  • International Prognostic Index (IPI) score of 0 to 2.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • More than 6 months life expectancy judged by the researchers.
  • At least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis.
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  • left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
  • Adequate hematologic function, no matter the bone marrow was attacked or not, as follows:absolute neutrophil count (ANC) ≥1.5×10^9/L and platelet count≥75×^9/L.
  • Understood and Signed an informed consent form.

Who cannot join

  • Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
  • Known allergic reactions against any component of CHOP regimen.
  • Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month.
  • T-cell/histiocyte-rich large B-cell lymphoma, Primary DLBCL of the CNS, Primary cutaneous DLBCL, leg type, EBV-positive DLBCL of the elderly (EBV + DLBCL), EBV-positive DLBCL of the elderly (EBV + DLBCL), DLBCL associated with chronic infammation, Lymphomatoid granulomatosis, Primary mediastinal (thymic) large B-cell lymphoma (PMBL), ALK-positive large B-cell lymphoma, ALK-positive large B-cell lymphoma, ALK-positive large B-cell lymphoma, high-grade B-cell lymphoma (high-grade B-cell lymphoma with MYC, with or without concurrent in BCL2 and/or BCL6 gene rearrangements, high-grade B-cell lymphoma, NOS), B-cell lymphoma, Not categorizable, Characteristics between DLBCL and classical Hodgkin's lymphoma, transformed DLBCL, DLBCL secondary central nervous system invasion;
  • Other malignant tumors that have been or are currently suffering (healed skin basal cell carcinoma or cutaneous squamous cell carcinoma, or cutaneous melanoma or cervical carcinoma in situ).
  • Significantly poorly controlled diseases that can affect adherence to the study protocol, such as severe cardiovascular disease (such as the New York Heart Association class III or IV heart disease, myocardial infarction or unstable arrhythmia in the last 6 months or Unstable angina, severe hypertension, peripheral nervous system or central nervous system disease;
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  • Patients with a history of progressive multifocal leukoencephalopathy.
  • Continuous corticosteroid treatment being received, dose >30 mg/day prednisone or equivalent dose of corticosteroids ≥10 days.
  • Participation in another interventional clinical trial in the past 3 months.
  • Patients who received or underwent major surgeries within 28 days prior to enrollment, or patients with unsurgical wounds.
  • Treated with transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to enrollment.
  • Vaccination within 28 days or planned prior to enrollment.
  • Appearing the following laboratory abnormal values.
  • Coagulation function: partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) or international normalized ratio (INR) > 1.5 times ULN without anticoagulant therapy.
  • Liver function: total bilirubin (TBIL) > 1.5 times the upper limit of normal (3 times the upper limit of normal value when the liver is invaded), alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal value (>5 times the upper limit of normal value when the liver is invaded)
  • Renal function: serum creatinine (Cr) > 1.5 times the upper limit of normal value.
  • an active infection at the time of enrollment, or any major infection events that affected the enrollment of the subjects determined by the investigator within 28 days (except for neoplastic fever).
  • Suspected active or latent tuberculosis infections.
  • HBsAg positive and/or HBcAb positive and HBV DNA positive.
  • HCV antibody and HCV-RNA positive; or HIV positive patients.
  • Pregnancy or breast feeding. Companion for women of childbearing age or women of childbearing age,who reluctant to take appropriate contraceptive methods within one year after the last treatment of the study;Pregnancy before pregnancy screening, the women who blood / urine results were positive.
  • Patients that researchers deem as not appropriate to enter the study.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites, 31 recruiting

  • No.8 Jiangtan Road,Weibin District

    Baoji

    Yazhou Yao, Doctor, 0917-3390942

    Recruiting

  • No. 87 Xiangya Road Furong District

    Changsha

    Xielan Zhao

    Not yet recruiting

  • No.138 Tongzipo Road Yuelu District

    Changsha

    Peiguo Cao, 0731-88618285

    Recruiting

  • No.139 Renmin Middle Road Furong District

    Changsha

    Chunhong Hu, 0731-85295929

    Recruiting

  • No. 37 Guoxue Lane Wuhou District

    Chengdu

    Yuping Gong

    Not yet recruiting

  • No. 55 Section 4 Renmin South Road Wuhou District

    Chengdu

    Zhihui Zhang, 028-85420057

    Recruiting

  • No. 10 Daping Yangtze River Branch Road Yuzhong District

    Chongqing

    Dong Wang, 023-68757150

    Recruiting

  • No.183 Xinqiao Main Street Shapingba District

    Chongqing

    Yao Liu, 023-68774309

    Recruiting

  • No.420 Fuma Road, Jin'an district

    Fuzhou

    Yu Yang, Doctor

    Not yet recruiting

  • No.150 Haping Road, Nangang District

    Haerbin, Heilongjiang, 150000

    Qingyuan Zhang, Doctor, 0451-86298681

    Recruiting

  • No.295 Xichang Road, Wuhua District

    Kunming

    Yun Zeng, 0871-65324888-2522

    Recruiting

  • No. 701 Donggang Road (West) Chengguan District

    Lanzhou

    Yaming Xi, 0931-8356912

    Recruiting

  • No. 82 Cuiyingmen Chengguan District

    Lanzhou

    Chongyang Wu, 0931-8943196

    Recruiting

  • No.333 Nanbinhe Middle Road Qilihe District

    Lanzhou

    Hai Bai, 0931-8995099

    Recruiting

  • No. 8 Wenchang Road Chengzhong District

    Liuzhou

    Jinxiong Huang, 0772-2662805

    Recruiting

  • No.519 Beijing East Road High - tech District

    Nanchang

    Yuerong Shuang, 0791-88329441

    Recruiting

  • No. 42 Baiziting Road, Xuanwu District

    Nanjing, Jiangsu

    Jifeng Feng, doctor, 025-83284615

    Recruiting

  • No.71 Embankment Road, Qingxiu District

    Nanning

    Hong Cen, Doctor, 0771-5390813

    Recruiting

  • No.20 Xisi Road Chongchuan District

    Nantong

    Hong Liu, 0513-81160502

    Recruiting

  • No.1677 Wutai Mountain Road Huangdao District

    Qingdao

    Hongwei Xue, 0532-82919699

    Not yet recruiting

  • No 137 Carp mountain Road New district

    Ürümqi

    Xinhong Guo, 0991-4361350

    Recruiting

  • No. 151 Guangwen Street Kuiwen District

    Weifang

    Xuehong Ran, 0536-8192116

    Recruiting

  • No. 3, West Mt. East Road, Wendeng District, Weihai City

    Weihai

    Binghua Wang, 0631-3793349

    Recruiting

  • No. 1277 Jiefang Avenue Jianghan District

    Wuhan

    Liling Zhang, 0278-5872257

    Recruiting

  • No.31 Hygienic Lane Haizang Road Liangzhou District

    Wuwei

    Youquan Dang, Doctor, 0935-2268046

    Cong Wang, Doctor

    Recruiting

  • No. 15 West ChangLe Road New City District

    Xi'an

    Guangxun Gao, 029-84775202

    Recruiting

  • No.256 Youyi West Road Beilin District

    Xi'an

    Yi Wang

    Not yet recruiting

  • No. 7 Weiwu Road Jinshui District

    Zhengzhou

    Zunmin Zhu, 0371-65896920

    Recruiting

  • No.1 Jianshe East Road Erqi District

    Zhengzhou

    Mingzhi Zhang

    Not yet recruiting

  • No.127 Dongming Road, Jinshuii District

    Zhengzhou

    Yufu Li, Doctor, 0371-65587306

    Recruiting

  • No. 54 Communist Youth League Road Zhangdian District

    Zibo

    Zhencheng Wang, 0533-2360985

    Recruiting

Other trials in China

About this study

Official title: Multicenter, Randomized, Double-blind, Parallel Controlled, Phase III Clinical Study to Compare the Efficacy and Safety of TQB2303 in Conbination With CHOP Regimen (T-CHOP) Versus Rituximab in Combination With CHOP Regimen (R-CHOP) in Previously Untreated Subjects With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)

The Purpose of This Study is to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics between TQB2303 and Rituximab in Combination With CHOP in Previously Untreated Patients with Diffuse Large B-cell Lymphoma

Being tested
TQB2303, Rituximab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2303Drug

    375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks

  • RituximabDrug

    375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks

Study groups in NCT03777085
Study groupRoleWhat they receive
TQB2303ExperimentalNot described
Receives: Drug: TQB2303
RituximabActive comparatorNot described
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    Measured: 18 weeks

Secondary outcomes (5)

  1. Objective Response Rate (CR+CRu)

    Measured: 18 weeks

  2. Progression-free survival (PFS)

    Measured: 18 weeks

  3. Event-free survival (EFS)

    Measured: 18 weeks

  4. Duration of Response (DOR)

    Measured: 18 weeks

  5. :Overall survival (OS)

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study start10 Jan 2019
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777085
Sponsor's protocol ID
TQB2303-III-01
Status last verified
May 2019
First submitted
13 Dec 2018
Last updated
30 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2303 and Rituximab in people with Diffuse Large B-cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03777085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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