NIPH Clinical Trials Search

UMIN ID: UMIN000001603

Registered date:26/12/2008

A multicenter phase II open-label study in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma evaluating efficacy and safety of maintenance therapy with IDEC-C2B8.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUntreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma.
Date of first enrollment2009/01/01
Target sample size58
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)In the induction phase, patients have to respond to 6 cycles of R-CHOP and 2 infusions of IDEC-C2B8 in order to move to the maintenance phase. After the maintenance period, patients will be followed-up for about 1.5 years additionally.


Primary OutcomeProgression-free survival (PFS) rate at the years of 4 (4-yr PFS rate).
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1)Treatment history i)With a history of other monoclonal antibody treatment. ii)Have participated in other clinical trial(s) for unapproved agent or treated with unapproved indication within 6 months prior to registration iii)Who received G-CSF within 7days prior to trial entry iv)With a history of sensitive or allergic to murine-derived materials v)Having received major surgery (excluding lymph node biopsy) within 28 days prior to registration 2)Follicular lymphoma Grade 3b 3)Tumor cells in peripheral blood > 10,000/uL 4)Co-existing medical conditions or previous disease i)Known HIV infection ii)Known active HBV or HCV infection and/or known positive in any one of HBs antigen, HBs antibody, HBc antibody or HCV antibody by laboratory tests within 28 days prior to registration 5)Patients with infections and serious underlying medical conditions which could impair the ability of the patient to participate in the trial 6)Patients who routinely use insulin by self injection. 7)Patients with prior or concomitant malignancies 8)Presence or history of CNS lymphoma infiltration 9)Serious psychological conditions 10)Women who are pregnant, breast feeding or positive of pregnant test. 11)Women and men who do not agree to use effective contraception during participation in the trial and for 12 months thereafter.

Related Information


public contact
Name Tsunehiko Ito
Address Japan
Telephone 03-3946-1113
Affiliation Zenyaku Kogyo Co., Ltd. Clinical Development
scientific contact
Name Kensei Tobinai, M.D., Ph.D.
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045 JAPAN Japan
Affiliation National Cancer Center Hospital Hematology Division