UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041182 |
|---|---|
| Receipt number | R000047023 |
| 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. |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2021/01/19 11:32:33 |
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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
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
h-kosugi@umin.ac.jp
Sponsor or person
Institute
Ogaki municipal hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047023
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| Registered date | File name |
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