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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012083
Receipt No. 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

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Basic information
Public 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
Acronym Safety of bendamustine-containing conditioning for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma
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
Scientific Title:Acronym Safety of bendamustine-containing conditioning for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma
Region
Japan

Condition
Condition Relapsed or refractory aggressive non-Hodgkin's B-cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes The maximum tolerated dose of bendamustine in a combination therapy with etoposide, cytarabine and melphalan
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A combination therapy of bendamustine, etoposide, cytarabine and melphalan as a conditioning regimen for autologous stem cell transplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 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)
Key exclusion criteria 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
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiko Mori
Organization Keio University School of Medicine
Division name Division of Hematology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email tmori@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Toyama
Organization Keio University School of Medicine
Division name Division of Hematology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email takt@a7.keio.jp

Sponsor
Institute Division of Hematology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Division of Hematology, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 20 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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