Rituximab Augmentation Following R-CHOP Induction Chemotherapy in Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

Sponsor
Chonnam National University Hospital
Study ID
NCT01181999
Phase
PHASE2
Status
Unknown

Conditions

  • Lymphoma, Large B-cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.

Study Details

Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) combination is considered as the new gold standard for the first-line treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL). The study is aimed to evaluate the overall response rate and the safety of four cycles of R-CHOP chemotherapy and followed by rituximab augmentation (weekly four times infusion) in newly diagnosed DLBCL patients with aged more than 70 years.

Key Dates

Start date
Aug 31, 2010
Status verified
Jul 2010
Primary completion
Mar 31, 2012
Completion
Sep 30, 2014

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab

Primary Outcome Measure

the overall response rate [ Time Frame: three years after the completion of rituximab augmentation ]

Central Contacts

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