UMIN-CTR Clinical Trial

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
Email	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
Email	ishidah@koto.kpu-m.ac.jp

Sponsor
Institute	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) Stem cell transplantation committee
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049775