UMIN-CTR Clinical Trial

Basic information
Public title	A single center Phase II study for the safety and efficacy of upfront high dose chemotherapy with thiotepa and busulfan followed by autologous peripheral blood stem cell transplantation for primary central nervous system lymphoma.
Acronym	P2 clinical trial of TT/BU with auto-PBSCT for PCNSL
Scientific Title	A single center Phase II study for the safety and efficacy of upfront high dose chemotherapy with thiotepa and busulfan followed by autologous peripheral blood stem cell transplantation for primary central nervous system lymphoma.
Scientific Title:Acronym	P2 clinical trial of TT/BU with auto-PBSCT for PCNSL
Region	Japan

Condition
Condition	primary central nervous system lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety and efficacy of upfront high dose chemotherapy with thiotepa and busulfan followed by autologous peripheral blood stem cell transplantation for primary central nervous system lymphoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	1.Safety: adverse event. 2.Efficacy: bone marrow suppression rate, engraftment rate, time to engraftment, and survival rate at Day 100 post-HSCT.
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	Busulfan 3.2mg/kg (d-8,-7,-6,-5) Thiotepa 5mg/kg (d-4,-3) ASCT (d0)
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	16 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with primary CNS lymphoma between 16 and 64 years of age. 2)Participants must sign the informed concent form (ICF). 3)Patients in first complete remission, and who had hematopoietic cells collected for autologous HSCT (CD34-positive cells >= 2x10^6/kg). 4)ECOG PS 0-2. 5)AST and ALT <= threefold, T-Bil and Cre <= 1.5-fold the reference range, left ventricular ejection fraction >= 50%, and eGFR >= 60 mL/min.
Key exclusion criteria	1)Other treatment for the management of underlying disease within 20 days prior to treatment initiation. 2)Patients with previous HSCT within 6 months prior to the study HSCT. 3)Patients with serious hypersensitivity to thiotepa or busulfan. 4)Patients with active infection. 5)Patients with positive test for hepatitis B surface antigen, HBV-DNA, hepatitis C virus antibody, or HIV. 6)Patients with cardiac effusion, pleural effusion, or ascites requiring treatment. 7)Patients with active double cancer. 8)Pregnant or lactating patients. 9)Patients who the investigator or subinvestigator judged as inappropriate for trial entry.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Kosugi
Organization	Ogaki municipal hospital
Division name	Department of Hematology
Zip code	503-8502
Address	4-86 Minaminokawa-cho, Ogaki City, Gifu
TEL	0584-81-3341
Email	h-kosugi@umin.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Kosugi
Organization	Ogaki municipal hospital
Division name	Department of Hematology
Zip code	503-8502
Address	4-86 Minaminokawa-cho, Ogaki City, Gifu
TEL	0584-81-3341
Homepage URL
Email	h-kosugi@umin.ac.jp

Sponsor
Institute	Ogaki municipal hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Ogaki municipal hospital Institutional Review Board
Address	4-86 Minaminokawa-cho, Ogaki City, Gifu
Tel	0584-81-3341
Email	clinical-trial@omh.ogaki.gifu.jp

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	大垣市民病院(岐阜県)

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 17 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	Enrolling by invitation
Date of protocol fixation	2020 Year 07 Month 13 Day
Date of IRB	2020 Year 07 Month 21 Day
Anticipated trial start date	2020 Year 08 Month 17 Day
Last follow-up date	2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 21 Day
Last modified on	2021 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047023