Unique ID issued by UMIN | UMIN000005428 |
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Receipt number | R000005907 |
Scientific Title | Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. |
Date of disclosure of the study information | 2011/04/12 |
Last modified on | 2020/04/19 17:21:01 |
Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Phase 1/2 study of Bendamustine and Rituximab for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Phase 1/2 study of the combination of Bendamustine and Rituximab for treatment of relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Phase 1/2 study of Bendamustine and Rituximab for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Japan |
relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
In the phase I trial, primary objective is to estimate the maximum tolerated dose(MTD) and recommended dose(RD) of bendamustine and rituximab relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
In the phase II trial, primary objectives is to evaluate the efficacy and safety.
Safety,Efficacy
Phase I,II
Phase 1
recommended dose
dose limiting toxicity
maximum tolerated dose
overall response rate
Phase 2
overall response rate
Phase 1
overall response rate
Phase 2
complete response rate
progression-free survival
safty
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bendamustine+Rituximab
Phase 1
Rituximab Day1 375mg/m2/day
Bendamustine Day2, Day3
Level 1: 90mg/m2/day, every 21 days
Level 2: 90mg/m2/day, every 28 days
Level 3: 120mg/m2/day, every 21 days
Level 4: 120mg/m2/day, every 28 days
Rituximab is infused on Day1 and Bendamustine infusedon Day1, Day2 after 2 cycles.
Phase 2
Domestic recommended dose decided by phase 1 part
20 | years-old | <= |
75 | years-old | > |
Male and Female
(1) Patients with pathologically confirmed indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma.
(2) Patients had received prior treatment of rituximab in combination with chemotherapy (without corticosteroid alone) or antibody treatments that rituximab alone or ibritumomab tiuxetan, and were considered no response or relapse after CR or PR.
(3) CD20 positive
(4) Patients have measurable lesion that measured >=1.5cm in a single dimension by CT.
(5) Patients aged 20-74 years.
(6) PS(ECOG) 0-2
(7) Patients meet all following standard
Absolute neutrophil count >= 1,500/mm3
Platelet count >= 100,000/mm3
AST and ALT < 2.5 times facility criteria.
Total bilirubin < 1.5 times facility criteria.
Creatinine < 1.5 times facility criteria.
Cardiac electro gram: no abnormality required treatment
SpO2: >= 90%
(8) Patients have a life expectancy > 3 months.
(9) Written informed consent.
(1) Patients are pregnant or lactating women.
Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment
(2) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
(3) Patients have mental disease or disorder with difficulty in participating in the clinical trial.
(4) HBs antigen positive
(5) HCV antibody positive
(6) HIV antibody positive
(7) Patients have much tumor cell in peripheral blood (>=25,000/mm3).
(8) Patients received allogeneic hematopoietic (hemopoietic) stem cell transplant.
(9) Patients have interstitial lung disease or fibroid lung.
(10) Patients have CNS invasion.
(11) Patients already received bendamustine treatment.
(12) Patients are inappropriate for rituximab treatment.
(13) Patients have severe allergic symptoms.
(14) Inadequate for clinical trial entry by the attending physicians.
40
1st name | Nozomi |
Middle name | |
Last name | Niitsu |
International Medical Center, Saitama Medical University
Department of Hematology
350-1298
1397 - 1, Yamane, Hidaka, Saitama, Japan
042-984-4111
ntakashi@saitama-med.ac.jp
1st name | Naoki |
Middle name | |
Last name | Takahashi |
International Medical Center, Saitama Medical University
Department of Hematology
350-1298
1397 - 1, Yamane, Hidaka, Saitama, Japan
042-984-4111
ntakashi@saitama-med.ac.jp
Department of Hematology, International Medical Center, Saitama Medical University
Department of Hematology, International Medical Center, Saitama Medical University
Other
IRB committee, International Medical Center, Saitama Medical University
1397 - 1, Yamane, Hidaka, Saitama, Japan
042-984-4111
chikens@saitama-med.ac.jp
NO
2011 | Year | 04 | Month | 12 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2011 | Year | 04 | Month | 12 | Day |
2020 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005907
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