Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459887
• Other study ID #: 304NHL-050617
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: October 25, 2011
• Start date: September 2006
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: Shanghai CP Guojian Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

CD20, the protein which is expressed on the surface of all mature B cells, is active in many B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL), the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases. This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP chemotherapy regimen compared with CHOP chemotherapy alone.

Description:

Rituximab, a chimeric anti-CD20 monoclonal antibody, has been proved valuable treatment for CD20-positive DLBCL. The combination of rituximab with CHOP has been shown to increase both survival and response rate, in comparison to CHOP alone. CMAB304(Retuxira), a biosimilar of rituximab, was developed by Shanghai CP Guojian Pharmaceutical Co.,Ltd. Previous Phase I study showed that CMAB304 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 250 to 500 mg/m2. In this study, efficacy and safety of CMAB304 were evaluated in DLBCL patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 70 year, male or female

2. Previously untreated

3. DLBCL patients with CD20-positive

4. Lymphoma lesions can be Measured and evaluated; Spiral CT or MR evaluation of the lesion must be = 1cm; Measured by clinical examination or others must be = 2cm

5. Normal blood test, adequate liver and renal function;

6. ECOG score 0~2

7. Life expectancy of greater than 3 months

8. No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

9. Signed ICF

Exclusion Criteria:

1. DLBCL transformed from other low-grade NHL types

2. Primary central nervous system lymphoma, or primary gastrointestinal DLBCL

3. History of foreign protein allergies

4. Abnormal liver and/or renal function

5. Suspected or diagnosed central nervous system violation

6. Serious infection or organic diseases

7. Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months

8. Breastfeeding or pregnant

9. Leukemia crisis or bone marrow metastases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• CHOP combined with CMAB304
Patients treated with CHOP-304 undergo 1 cycle every 3 weeks, received CMAB304 at a dose of 375 mg/m2 on day 1 and CHOP on day 2 of each of the 6 cycles.
• CHOP, CMAB304
First standard CHOP, then sequential CMAB304 in patients who reached a complete response or undocumented complete response at the end of treatment of 6 cycles.

Locations

Country	Name	City	State
China	SUN-YAT-SEN university cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai CP Guojian Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	Tumor responses were assessed after 6 cycles of CMAB304-CHOP or 6 cycles of CHOP alone and classified as CR,CRu,PR,SD or PD.	up to 18 weeks	Yes
Secondary	event-free survival	Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause.	From date of randomization until the date of first documented progression or relapse, institution of a new anticancer treatment, or death from any cause, whichever came first, assessed up to 50 months	Yes