UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)
Title of the study (Brief title)	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	Koji Izutsu
Organization	Toranomon Hospital
Division name	Department of Hematology
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	Koji Izutsu
Organization	Toranomon Hospital
Division name	Department of Hematology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016251