UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043591 |
|---|---|
| Receipt number | R000049775 |
| Scientific Title | An exploratory study of the relationship between pharmacokinetics of melphalan and early post-hematopoietic stem cell transplant complications in allogeneic transplantation using conditioning regimen consisting of fludarabine, cytarabine, melphalan, and low-dose total body irradiation |
| Date of disclosure of the study information | 2021/03/12 |
| Last modified on | 2021/09/10 15:39:08 |
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Basic information
Public title
Relationship between pharmacokinetics of melphalan and early post-hematopoietic stem cell transplant complications
Acronym
SCT-MEL-AUC20
Scientific Title
An exploratory study of the relationship between pharmacokinetics of melphalan and early post-hematopoietic stem cell transplant complications in allogeneic transplantation using conditioning regimen consisting of fludarabine, cytarabine, melphalan, and low-dose total body irradiation
Scientific Title:Acronym
SCT-MEL-AUC20
Region
| Japan |
Condition
Condition
Acute myelogenous leukemia
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To obtain basic data on the pharmacokinetics of melphalan in children undergoing allogeneic hematopoietic stem cell transplantation and its relationship to early post-transplant complications
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between melphalan-AUC and the frequency of CTC-AE grade 3 or higher for dysphagia and diarrhea up to 28 days after transplantation
Key secondary outcomes
1) Melphalan clearance
2) A relationship between melphalan-AUC and the following parameters:
i) age, dose per body weight, pre-transplant Creatinine (Cr), 24-hour Cr clearance, Cystatin-C, and eGFR.
ii) Maximum Cr value, minimum eGFR estimated from Cr up to 28 days after transplantation
iii) First day of febrile neutropenia and number of days with fever up to 28 days after transplantation
iv) First day of opioid use and duration of opioid use up to 28 days after transplantation
3) After completion of the primary analysis of the AML-SCT15 study, the relationship with cumulative incidence of relapse and leukemia-free survival will also be examined.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients enrolled in AML-SCT15 at a facility participating in the Japan children cancer Group (JCCG) subcommittee on hematological malignancies (JPLSG) who plan to undergo allogeneic transplantation using the FLAMEL regimen and who have obtained written consent from a surrogate for participation in this study
Key exclusion criteria
Patients with any other inappropriate status judged by physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Ishida |
| Middle name | |
| Last name | Hiroyuki |
Organization
Kyoto City Hospital
Division name
Department of Pediatrics
Zip code
604-8845
Address
1-2, Higashitakada-cho, Mibu, Nakagyou-ku, Kyoto
TEL
075-311-5311
ishidah@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Ishida |
| Middle name | |
| Last name | Hiroyuki |
Organization
Kyoto City Hospital
Division name
Department of Pediatrics
Zip code
604-8845
Address
1-2, Higashitakada-cho, Mibu, Nakagyou-ku, Kyoto
TEL
075-311-5311
Homepage URL
ishidah@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) Stem cell transplantation committee
Institute
Department
Personal name
Funding Source
Organization
Gold Ribbon Network
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto City Hospital
Address
1-2, Higashitakada-cho, Mibu, Nakagyou-ku, Kyoto
Tel
075-311-5311
nfujita@kch-org.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 12 | 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 | 11 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Return of melphalan pharmacokinetic to the attending physician
Management information
Registered date
| 2021 | Year | 03 | Month | 11 | Day |
Last modified on
| 2021 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049775
