Unique ID issued by UMIN | UMIN000012083 |
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Receipt number | R000014097 |
Scientific Title | Safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma: a clinical phase I study |
Date of disclosure of the study information | 2013/10/21 |
Last modified on | 2018/04/26 10:10:05 |
Safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma: a clinical phase I study
Safety of bendamustine-containing conditioning for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma
Safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma: a clinical phase I study
Safety of bendamustine-containing conditioning for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma
Japan |
Relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for refractory/relapsed aggressive non-Hodgkin's B-cell lymphoma and to determine the optimal dose of bendamustine
Safety
Phase I
The maximum tolerated dose of bendamustine in a combination therapy with etoposide, cytarabine and melphalan
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
A combination therapy of bendamustine, etoposide, cytarabine and melphalan as a conditioning regimen for autologous stem cell transplantation
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) Patients with aggressive non-Hodgkin's B-cell lymphoma who are refractory to/relapsed after one or more prior chemotherapies
2) Patients in PR or CR after salvage regimen
3) Patients whose CD34+ cells are collected at a dose of more than 2.0x10^6 cells/kg
4) Patients with ECOG PS 0-1
5) Patients with adequate liver function: AST <2.5x ULN, ALT <2.5x ULN, T-Bil <2x ULN (except for disease activity)
6) Patients with adequate renal function: GFR >50 ml/min
7) Patients with adequate pulmonary function: %VC >80%, FEV1.0/FVC >70%
8) Patients with adequate cardiac function: EF >50% (assessed on cardiac ultrasonography)
1) Patients with concomitant active cancer
2) Patients with active viral hepatitis or HBs-Ag positive
3) Patients with known CNS involvement of the lymphoma
4) Patients with previous serious allergy to any of the drugs given
5) Patients with abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or poor compliance of antihypertensive treatment, uncontrolled arrhythmias
6) Patients with serious or uncontrolled medical condition such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease
7) Patients unable to give written informed consent
8) Others: Inappropriate patients determined by a principal investigator or sub-investigators
18
1st name | |
Middle name | |
Last name | Takehiko Mori |
Keio University School of Medicine
Division of Hematology
35 Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
tmori@a3.keio.jp
1st name | |
Middle name | |
Last name | Takaaki Toyama |
Keio University School of Medicine
Division of Hematology
35 Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
takt@a7.keio.jp
Division of Hematology, Keio University School of Medicine
Division of Hematology, Keio University School of Medicine
Self funding
NO
慶應義塾大学病院(東京都)
2013 | Year | 10 | Month | 21 | Day |
Unpublished
Terminated
2013 | Year | 07 | Month | 07 | Day |
2013 | Year | 10 | Month | 21 | Day |
2013 | Year | 10 | Month | 20 | Day |
2018 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014097
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