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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013940
Receipt No. R000016251
Scientific Title Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)
Date of disclosure of the study information 2014/05/13
Last modified on 2018/11/15

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Basic information
Public title Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)
Acronym Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with fludarabine, iv busulfan, and melphalan.
Scientific Title Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)
Scientific Title:Acronym Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with fludarabine, iv busulfan, and melphalan.
Region
Japan

Condition
Condition Relapsed or refractory aggressive non Hodgkin lymphomas (NHL)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess safety and efficacy of allogeneic stem cell transplantation with conditioning regimen consisted of fludarabine 180 mg/m2, iv busulfan 12.8 mg/kg, and melphalan 80 mg/kg in patients with relapsed or refractory aggressive NHL.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Survival rate with engraftment on day 60 after transplantation
Key secondary outcomes Survival rate with engraftment on day 100.
Grade>=3 AEs from start of conditioning to day 100 after transplantation.
Non relapse mortality at day 100, 12 months after transplantation.
Relapse rate at day 100, 12 months after transplantation.
Event free survival rate at 12 months after transplantation.
Overall survival at 12 months after transplantation.
Rate of infectious disease at 12 months after transplantation.
Rate and severity of acute or chronic graft-versus-host disease at 12 months after transplantation.

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 Allogeneic stem cell transplantation with conditioning regimen consisted of fludarabine 180 mg/m2, iv busulfan 12.8 mg/kg, and melphalan 80 mg/kg.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Candidates for allogeneic stem cell transplantation who fulfill each criteria.
1) ECOG performance status: 0-2, no severe organ dysfunction.
2) Relapse or refractory aggressive NHL (progressive disease during first-line chemotherapy, early relapse (<12 mo) after first-line chemotherapy, less than PR with salvage chemotherapy, relapse after high dose chemotherapy associated with autologous hematopoietic stem cell transplantation, mobilization failure)
3) >=stable disease with recent salvage chemotherapy.
4) Donor availability: HLA A/B/DR 6-locus matched related/unrelated bone marrow, related peripheral blood, cord blood >=2x10^7/kg with disparity <=2 antigens.
Key exclusion criteria Positive for anti-HIV antibody
Active double cancer
Severe mental conditions
Active infectious disease
Known hypersensitivity to drugs to be used in the protocol.
Not appropriate for enrollment as judged by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Izutsu
Organization Toranomon Hospital
Division name Department of Hematology
Zip code
Address Toranomon 2-2-2, Minato-ku, Tokyo 105-8470, Japan
TEL 03-3588-1111
Email izutsu-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Izutsu
Organization Toranomon Hospital
Division name Department of Hematology
Zip code
Address Toranomon 2-2-2, Minato-ku, Tokyo 105-8470, Japan
TEL 03-3588-1111
Homepage URL
Email izutsu-tky@umin.ac.jp

Sponsor
Institute Department of Hematology
Toranomon Hospital
Institute
Department

Funding Source
Organization Department of Hematology
Toranomon Hospital
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 虎の門病院(東京都)、虎の門病院分院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 13 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 Completed
Date of protocol fixation
2014 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 19 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
2014 Year 05 Month 13 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016251

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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