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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033003
Receipt No. R000037630
Scientific Title Circulating tumor DNA for minimal residual disease in acute myeloid leukemia after allogeneic hematopoietic stem cell transplant: a multi-center prospective study.
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/15

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Basic information
Public title Circulating tumor DNA for minimal residual disease in acute myeloid leukemia after allogeneic hematopoietic stem cell transplant: a multi-center prospective study.
Acronym ctDNA for MRD with AML after transplant.KSGCT1702(ctDNA)
Scientific Title Circulating tumor DNA for minimal residual disease in acute myeloid leukemia after allogeneic hematopoietic stem cell transplant: a multi-center prospective study.
Scientific Title:Acronym ctDNA for MRD with AML after transplant.KSGCT1702(ctDNA)
Region
Japan

Condition
Condition Acute Myeloid Leukemia, Myelodysplastic Syndromes
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the impact of circulating tumor DNA on relapse and prognosis in patients with acute myeloid leukemia after allogeneic hematopoietic stem cell transplant
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate 1-year cumulative incidence of relapse rate according to circulating tumor DNA status post allogeneic hematopoietic stem cell transplant
Key secondary outcomes 1. To evaluate 1-year overall survival rate according to circulating tumor DNA status post allogeneic hematopoietic stem cell transplant
2. To compare the utility of circulating tumor DNA status and conventional biomarkers
3. To compare the profiles of the somatic mutation, gene expression, and immunological cell status between diagnostic and relapsed samples from bone marrow or peripheral blood

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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Any patient (age >= 20 yo and =< 65 yo) with acute myelogenous leukemia (except for acute promyelocytic leukemia) or myelodysplastic syndromes by WHO2008 criteria
2. Any patient with any disease status or any history/sensitivity of chemotherapy at allogeneic stem cell transplant
3. Patient must have adequate tumor samples at diagnosis or relapse available for analyses (tumor proportion more than 20%)
4. Any patient who have no history of allogeneic stem cell transplant, for whom an myeloablative allogeneic stem cell transplant is warranted
5. Any patient who have signed informed consent available with regard to this study
Key exclusion criteria 1. Any patient who decline to register
2. Any patient who are considered as inappropriate to register by attending physician
Target sample size 70

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

Public contact
Name of contact person
1st name
Middle name
Last name Kazuaki Yokoyama
Organization Research Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Hematology/Oncology
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-0071
TEL 03-3443-8111
Homepage URL
Email ksgctdc@ksgct.net

Sponsor
Institute Kanto Study Group for Cell Therapy
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 06 Month 15 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
2018 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information With the recent advent of molecular techniques, such as droplet digital polymerase chain reaction (ddPCR), tumor-derived fragmented DNA in the plasma or serum, known as circulating tumor DNA (ctDNA), represents one of the most sensitive, non-invasive biomarkers available for use in cancer patients. Successful applications of such so-called liquid biopsy techniques reported to-date include the monitoring of tumor burden and minimal residual disease (MRD), evaluation of tumor clonal heterogeneity; prediction of response to treatment with molecularly targeted drugs; and detection of metastasis in many solid tumor types and hematological malignancies. Several recent studies have indicated that ctDNA quantification can be used as an alternative to conventional MRD detection modalities for hematological malignancies. Of these, Nakamura and Yokoyama et al. performed a retrospective study in 31 patients with AML and MDS undergoing allogeneic hematopoietic stem cell transplant (alloSCT) in their research hospital. They investigated the impact of residual ctDNA status on cumulative incidence of relapse (CIR) and overall survival (OS) rate. The result was as follows: 1) Diagnostic ctDNA and matched tumor had excellent correlations with regard to variant allele frequencies. 2) Residual ctDNA persistence either at 1month or 3 months post alloSCT was associated with higher 3-year cumulative incidence of relapse and inferior OS rates.

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037630

Research Plan
Registered date File name

Research case data specifications
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Research case data
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