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Study of TQB2303 in Patients With Aggressive CD20 Positive Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT03456466
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:

Primary Outcome Measures:

Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ]

Secondary Outcome Measures:

The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).


Condition or disease Intervention/treatment Phase
Non-hodgkin's Lymphoma Drug: TQB2303 Drug: Rituximab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: TQB2303 and Rituximab
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Parallel Control Clinical Trial to Assess the Similarity of the Safety and Pharmacokinetics of TQB2303 in Combination With Rituximab to Patients With AggressiveCD20 Positive Non-Hodgkin's Lymphoma
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: TQB2303 Drug: TQB2303
375mg/m2 ,iv

Active Comparator: Rituximab Drug: Rituximab
375mg/m2 ,iv




Primary Outcome Measures :
  1. AUC [ Time Frame: 85 days ]
    Area under the curve (AUC) forTQB2303 and rituximab concentrations

  2. Cmax [ Time Frame: 85 days ]
    The Maximum Concentration (Cmax) of the TQB2303 and rituximab

  3. AUC0-∞ [ Time Frame: 85 days ]
    The area under the plasma concentration-time curve from 0 to inf (infinite) time

  4. Tmax [ Time Frame: 85 days ]
    The time to reach the maximum plasma concentration after treatment

  5. CL [ Time Frame: 85 days ]
    Total clearance

  6. t1/2 [ Time Frame: 85 days ]
    Elimination of half-life

  7. Vd [ Time Frame: 85 days ]
    Apparent distribution volume


Secondary Outcome Measures :
  1. Evaluation of immunogenicity [ Time Frame: 85 days ]
    Anti-drug antibody (ADA), neutralizing antibody (Nab detection when ADA positive)

  2. Change of CD19+ CD20+ B-cells from baseline [ Time Frame: 85 days ]
    Change of CD19+ CD20+ B-cells from baseline



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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. Patients should participate in the study voluntarily and sign informed consent;
  2. CD20-positive non-Hodgkin's lymphoma (NHL):Diffuse Large B-cell Lymphoma;Mantle Cell Lymphoma;Follicular Lymphoma;Marginal Zone Lymphoma;
  3. having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;And the investigators believe that CD20-positive B-cell NHL patients can benefit from anti-CD20 monoclonal antibody therapy;
  4. aged from 18 to 75 years;
  5. ECOG PS:0-1;
  6. Life expectancy of more than 3 months

Exclusion Criteria:

  1. Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
  2. patients who were treated with antitumor therapy (including corticosteroid therapy) within 4 weeks prior to enrollment, or who had not recovered from the toxicity of the previous treatment;
  3. Patients who participated in other clinical studies within 30 days ;
  4. Serious hematologic dysfunction (white blood cell count of <3.0×10^9/L; absolute neutrophil count of <1.5×10^9/L; platelet count of < 75×10^9/L; hemoglobin level of <80g/L); In the absence of anticoagulant therapy, International Standardization Ratio (INR)> 1.5× ULN;Partial prothrombin time (PTT)Or activated partial thromboplastin time (aPTT)> 1.5 × ULN;) Hepatic dysfunction (total bilirubin level of > 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN;) renal dysfunction (serum creatinine level of > 1.5×ULN );
  5. Other invasive malignancies except for cured the IB or lower level of cervical cancer; Non-invasive basal cells or squamous cell skin cancer; Get CR> 10 years of breast cancer;Get CR> 10 years of malignant melanoma;or other malignancies with CR> 5 years;
  6. Central nervous system (CNS) lymphoma, AIDS-associated lymphoma;
  7. Active infections and other serious non-malignant tumor diseases, Such as Qualitative pneumonia, Severe organic cardiovascular disease, Heart conduction block > 2,Myocardial infarction in 6 months, Cerebral infarction in 3 months,Cerebral hemorrhage,Thyroid dysfunction (TSH lower than the normal lower limit or higher than the upper limit of normal, and the researchers have a clinical significance);
  8. Seropositive for HIV , HCV antibody; Or one of the following HBV findings :

    1. HBsAg positive;
    2. HBsAg negative, HBcAb positive and HBV DNA positive;
  9. Plan major surgery, or surgical wound unhealed patients;
  10. History of severe allergies, protein products and mouse products such as allergies;
  11. 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;
  12. Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
  13. Researchers think that do not fit into the group.

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): NCT03456466


Locations
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China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Jifeng feng, doctor    025-83233303    fjif@vip.sina.com   
First Affiliated Hospital of Suzhou University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Depei wu, doctor    0512-67780040    drwudepei@163.com   
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: NCT03456466     History of Changes
Other Study ID Numbers: TQB2303-I-01
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 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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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents