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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043591
Receipt No. 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

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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
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/ctr_e/ctr_view.cgi?recptno=R000049775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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