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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

CHOP combined with CMAB304

CHOP, CMAB304

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring untreated, CD20-positive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age from 18 to 70 year, male or female
Previously untreated
DLBCL patients with CD20-positive
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
Normal blood test, adequate liver and renal function;
ECOG score 0~2
Life expectancy of greater than 3 months
No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
Signed ICF

Exclusion Criteria:

DLBCL transformed from other low-grade NHL types
Primary central nervous system lymphoma, or primary gastrointestinal DLBCL
History of foreign protein allergies
Abnormal liver and/or renal function
Suspected or diagnosed central nervous system violation
Serious infection or organic diseases
Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months
Breastfeeding or pregnant
Leukemia crisis or bone marrow metastases

Sites / Locations

SUN-YAT-SEN university cancer center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

combination group

sequential group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

event-free survival

Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause.

Full Information

NCT ID

NCT01459887

First Posted

October 18, 2011

Last Updated

October 25, 2011

Sponsor

Shanghai CP Guojian Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01459887

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai CP Guojian Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

Keywords

untreated, CD20-positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

278 (Actual)

8. Arms, Groups, and Interventions

Arm Title

combination group

Arm Type

Experimental

Arm Title

sequential group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CHOP combined with CMAB304

Other Intervention Name(s)

cyclophosphamide, doxorubicin, vincristine, prednisone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CHOP, CMAB304

Other Intervention Name(s)

cyclophosphamide, doxorubicin, vincristine, prednisone

Intervention Description

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.

Primary Outcome Measure Information:

Title

overall response rate

Description

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.

Time Frame

up to 18 weeks

Secondary Outcome Measure Information:

Title

event-free survival

Description

Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age from 18 to 70 year, male or female Previously untreated DLBCL patients with CD20-positive 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 Normal blood test, adequate liver and renal function; ECOG score 0~2 Life expectancy of greater than 3 months No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer Signed ICF Exclusion Criteria: DLBCL transformed from other low-grade NHL types Primary central nervous system lymphoma, or primary gastrointestinal DLBCL History of foreign protein allergies Abnormal liver and/or renal function Suspected or diagnosed central nervous system violation Serious infection or organic diseases Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months Breastfeeding or pregnant Leukemia crisis or bone marrow metastases

Overall Study Officials: