Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL

Sponsor
Asan Medical Center
Study ID
NCT01279902
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab plus CHOP Immunochemotherapy — DRUG
    The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).

Study Details

This study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.

Key Dates

Start date
Aug 31, 2010
Status verified
Jul 2016
Primary completion
Aug 31, 2016
Completion
Jan 31, 2017

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab plus CHOP Immunochemotherapy
    Interventions: conventional R-CHOP every 3 weeks for 3 cycles * Rituximab 375 mg/M2 IV day 1 * Cyclophosphamide 750 mg/M2 IV day1 * Vincristine 1.5 mg/M2 (max. 2 mg) IV day1 * Prednisolone 50 mg bid day 1-5, every 3 weeks

Primary Outcome Measure

Disease-free survival [ Time Frame: 2 years ]

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