Unique ID issued by UMIN | UMIN000001603 |
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Receipt number | R000001923 |
Scientific Title | 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. |
Date of disclosure of the study information | 2008/12/26 |
Last modified on | 2013/12/19 10:33:51 |
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.
Japanese Phase II study for Rituximab Maintenance
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.
Japanese Phase II study for Rituximab Maintenance
Japan |
Untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma.
Hematology and clinical oncology |
Malignancy
NO
To assess efficacy and safety of maintenance therapy with IDEC-C2B8 after induction with 6 cycles of R-CHOP followed by 2 infusions of IDEC-C2B8 in untreated patients with CD20 positive indolent B-cell non-Hodgkin's lymphoma.
Safety,Efficacy
Phase II
Progression-free survival (PFS) rate at the years of 4 (4-yr PFS rate).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1)Confirmed CD20 positive indolent NHL
2)Patients previously untreated with chemotherapy immunotherapy, immunochemotherapy, immunoradiotherapy.
3)Patients with at least one of the following signs or symptoms requiring initiation of treatment:
i)Bulky disease at study entry: nodal or extra-nodal mass (except spleen) > 7cm in its greater diameter
ii)B symptoms
iii)Elevated serum LDH or beta2-microglobulin
iv)involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
v)symptomatic splenic enlargement
vi)Compressive syndrome
vii)Pleural/peritoneal effusion
- Life expectancy > 6 months.
4)Performance status < 2 on the ECOG scale.
5)Patients between 20 years and 80 years.
6)Adequate organ function within 28 days
i) Hematological function
-Absolute neutrophil counts > 1,500/uL
-Platelet conts > 100,000/uL
-Hemoglobin > 8.0g/dL
ii) Hepatic function
-AST < 3.0 x the upper limit of normal
-ALT < 3.0 x the upper limit of normal
-Total bilirubin < 2.0 mg/dL
iii) Renal function
-Serum creatinine < 2.0 mg/dL
iv) Cardiac function
-LVEF > 50%
-PaO2 > 65 mmHg
7)Hospitalization
8)Patients who signed a written informed consent form.
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.
58
1st name | |
Middle name | |
Last name | Kensei Tobinai, M.D., Ph.D. |
National Cancer Center Hospital
Hematology Division
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045 JAPAN
1st name | |
Middle name | |
Last name | Tsunehiko Ito |
Zenyaku Kogyo Co., Ltd.
Clinical Development
03-3946-1113
Zenyaku Kogyo Co., Ltd.
Zenyaku Kogyo Co., Ltd.
Profit organization
NO
2008 | Year | 12 | Month | 26 | Day |
Unpublished
Completed
2008 | Year | 11 | Month | 15 | Day |
2009 | Year | 01 | Month | 01 | Day |
2013 | Year | 11 | Month | 29 | Day |
2008 | Year | 12 | Month | 26 | Day |
2013 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001923
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