UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective observational study on minimal residual disease of ALL after allogeneic transplantation using circulating cell-free tumor DNA KSGCT1901(ctALL)
Acronym	Prospective study on MRD of ALL after transplant using ctDNA, KSGCT1901(ctALL)
Scientific Title	Multicenter prospective observational study on minimal residual disease of ALL after allogeneic transplantation using circulating cell-free tumor DNA KSGCT1901(ctALL)
Scientific Title:Acronym	Prospective study on MRD of ALL after transplant using ctDNA, KSGCT1901(ctALL)
Region	Japan

Condition
Condition	Acute lymphocytic leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the usefulness of predicting relapse of ALL after transplant using ctDNA monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	One-year cumulative incidence of ALL relapse
Key secondary outcomes	One-year overall survival, Somatic gene mutation, gene expression and immune cell profile at initial diagnosis and relapse

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients age >= 16 years 2) Precursor Lymphoid neoplasms, Chronic myeloid leukeamia, BCR-ABL1-positive in blastic phase (not including myeloid crisis), and mixed-phenotype acute leukeamia with t(9;22) 3) No limit on the disease stage or chemosensitivity at the time of transplant 4) Patients in which a high-quality sample with a tumor volume of 20% or more (at the time of initial diagnosis or relapse) is available. 5) Patients who may undergo allogeneic transplantation at the time of registration. 6)Patients who were informed and concented
Key exclusion criteria	Patients who are otherwise classified as unfit by the attending physicians for this research.
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Okamoto
Organization	Kanto Study Group for Cell Therapy
Division name	Chairman
Zip code	186-0004
Address	Tokyo
TEL	042-505-4251
Email	ksgctdc@ksgct.net

Public contact
Name of contact person	1st name Hiroto Middle name Last name Ishii
Organization	Jikei University School of Medicine
Division name	Division of Clinical Oncology and Hematology
Zip code	105-8471
Address	3-19-18 Nishishinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	ksgctdc@ksgct.net

Sponsor
Institute	Kanto Study Group for Cell Therapy
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jikei University School of Medicine
Address	3-25-8 Nishishinbashi, Minato-ku, Tokyo
Tel	03-3433-1111
Email	rinri@jikei.ac.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	2020 Year 03 Month 23 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	Open public recruiting
Date of protocol fixation	2020 Year 02 Month 10 Day
Date of IRB	2020 Year 02 Month 10 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design:prospective observational study Under the collection of cases at multi-institutional collaboration study

Management information
Registered date	2020 Year 03 Month 22 Day
Last modified on	2021 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045505