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.

UMIN ID: UMIN000001603

Registered date:26/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma.
• Date of first enrollment: 2009/01/01
• Target sample size: 58
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Progression-free survival (PFS) rate at the years of 4 (4-yr PFS rate).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)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

• Primary Sponsor: Zenyaku Kogyo Co., Ltd.
• Source(s) of Monetary Support: Zenyaku Kogyo Co., Ltd.