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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


Phase 3
18 Years
70 Years
Not Enrolling
Both
Diffuse Large B Cell Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall response rate

Outcome 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.

Outcome Time Frame:

up to 18 weeks

Safety Issue:

Yes

Principal Investigator

Jun Zhu, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

304NHL-050617

NCT ID:

NCT01459887

Start Date:

September 2006

Completion Date:

February 2011

Related Keywords:

  • Diffuse Large B Cell Lymphoma
  • untreated, CD20-positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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