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

Non-hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03456466
• Other study ID #: TQB2303-I-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 23, 2017
• Last updated: March 5, 2018
• Start date: May 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2018
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkin's Lymphoma

Intervention

Drug:
• TQB2303
375mg/m2 ,iv
• Rituximab
375mg/m2 ,iv

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	Area under the curve (AUC) forTQB2303 and rituximab concentrations	85 days
Primary	Cmax	The Maximum Concentration (Cmax) of the TQB2303 and rituximab	85 days
Primary	AUC0-8	The area under the plasma concentration-time curve from 0 to inf (infinite) time	85 days
Primary	Tmax	The time to reach the maximum plasma concentration after treatment	85 days
Primary	CL	Total clearance	85 days
Primary	t1/2	Elimination of half-life	85 days
Primary	Vd	Apparent distribution volume	85 days
Secondary	Evaluation of immunogenicity	Anti-drug antibody (ADA), neutralizing antibody (Nab detection when ADA positive)	85 days
Secondary	Change of CD19+ CD20+ B-cells from baseline	Change of CD19+ CD20+ B-cells from baseline	85 days