Unique ID issued by UMIN | UMIN000004205 |
---|---|
Receipt number | R000004947 |
Scientific Title | Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma |
Date of disclosure of the study information | 2010/09/15 |
Last modified on | 2012/06/28 11:04:30 |
Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma
Phase II trial of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell lymphoma
Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma
Phase II trial of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell lymphoma
Japan |
Malignant lymphoma, non-Hodgkin lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged MALT lymphoma and nodal marginal zone B-cell lymphoma
Safety,Efficacy
Exploratory
Phase II
Two-year progression-free survival
Complete response rate
Overall response rate
Two-year overall survival rate
Time to response
Remission duration
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination therapy of rituximab and cladribine
20 | years-old | <= |
79 | years-old | >= |
Male and Female
1. Histologically confirmed extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue and nodal marginal zone B-cell lymphoma
2. CD20-positivity on lymphoma cells by immunohistochemical staining and/or flow cytometry.
3. Clinical stage 3 or 4 by Ann Arbor criteria.
4. At least 1 measurable lesion more than 1.5 cm in at least one dimension by computed tomography, if not any lesions defined by computed tomograghy, magnetic resonance imaging, positron emission tomograghy or endoscopy.
5. No prior chemotherapiy or immunotherapy.
6. Expected to survive for at least 3 months.
7. Performance status (ECOG) of 0 to 2
8. Age 20-79 years
9. No major organ dysfunction
(1) Neutrophil counts:more than or equal to 1200/uL
(2) Platelet counts:more than or equal to 100000/uL.
(3) Hemoglobin more than or equal to 8.0 g/dl
(4) Serum bilirubin:less than or equal to 2 x upper limit of normal (In cases with lymphomatous involvement, 5 times and less is allowed.)
(5) AST(GOT):less than or equal to 2.5 x upper limit of normal
ALT(GPT):less than or equal to 2.5 x upper limit of normal
(6) Serum creatinin:less than or equal to 1.5 x upper limit of normal
(7) SpO2:more than or equal to 90 percent
(8) No abnormalities that require treatment on ECG
10. Patient's written informed consent
(1) Histologically transformed lymphoma.
(2) History of glaucoma
(3) Peripheral lymphoma cells> 5000/uL
(4) Serious bacterial or viral infections.
(5) Positive for HBs antigen, HCV antibody or HIV antibody
(6) Active cancer or history of malignancies within 5 years, except for carcinoma in situ
(7) Interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema.
(8) Serious complications (cardiac failure, hepatic failure or renal failure)
(9) Psychological complications judged to be difficult to enroll
(10) Active disease or history of autoimmune anemia.
(11) Serious bleeding tendencies (e.g. disseminated intravascular coagulation)
(12) Patients who received granulacyte colony stimulating factor within 2 weeks before registration.
(13) Active or suggestive CNS involvement
(14) Patients who are pregnant or lactating
(15) Inadequate patients to enroll judged by investigators
43
1st name | |
Middle name | |
Last name | Michinori Ogura |
Nagoya Daini Red Cross Hospital
Hematology and Oncology
2-9 Myoken-cho Shouwa-ku Nagoya, JAPAN
052-832-1121
1st name | |
Middle name | |
Last name | Michinori Ogura, Tatsuya Suzuki |
Nagoya Daini Red Cross Hospital
Hematology and Oncology
2-9 Myoken-cho Shouwa-ku Nagoya, JAPAN
052-832-1121
Hematological Malignancy Clinical Study Group
None
Self funding
NO
2010 | Year | 09 | Month | 15 | Day |
Unpublished
Open public recruiting
2010 | Year | 07 | Month | 20 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 14 | Day |
2012 | Year | 06 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004947
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |