UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018791
Receipt No. R000021743
Scientific Title Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2015/08/25
Last modified on 2020/03/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation.
Acronym Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation for high risk MDS.
(KSGCT1501, MDS-AZA-P1)
Scientific Title Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation for high risk MDS.
(KSGCT1501, MDS-AZA-P1)
Region
Japan

Condition
Condition Myelodysplastic syndrome(MDS)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Dose finding study of maintenance therapy with Azacitidine after allogeneic hematopoietic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Estimate of feasible initial dose
Completion rate of total 4 cycles
Key secondary outcomes (1) Incidence of dose limiting toxicity
(2) Incidence of adverse events
(3) Time to progression

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Azacitidine 20 mg/m2/day, 5days
Interventions/Control_2 Azacitidine 30 mg/m2/day, 5days
Interventions/Control_3 Azacitidine 40 mg/m2/day, 5days
Interventions/Control_4 Azacitidine 50 mg/m2/day, 5days
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Age between 18 and 65 years-old
(2) After receiving allogeneic hematopoietic stem cell transplant for high-risk MDS (IPSS int-2 or high) in FAB classification.
(3) Engraftment with sufficient hematopoiesis
(4) Remission after allogeneic stem cell transplant
(5) Between days 40 and 180 post-transplantation
(6) ECOG performance status score 0 to 2
(7) Enough organ function
(8) With written informed consent
Key exclusion criteria (1) Allergic to azacitidine
(2) With active uncontrollable infectious diseases
(3) With severe mental disorder
(4) With severe acute GHVD Grade III to IV
(5) Requiring 2nd line therapy for acute GVHD due to unsuccessful 1st line therapy
(6) Uncontrollable chronic GVHD
(7) Under treatment of anti-CMV drug
(8) Those evaluated ineligible by attending doctors
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichiro Okamoto
Organization Kanto Study Group for Cell Therapy
Division name Chairman
Zip code
Address Tokyo
TEL 03-6225-2040
Email ksgctdc@ksgct.net

Public contact
Name of contact person
1st name
Middle name
Last name Yuho Najima
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
Division name Hematology division
Zip code
Address 3-18-22 Honkomagome Bunkyo-ku Tokyo, 113-8677, Japan.
TEL 03-3823-2101
Homepage URL
Email yuhonajima@cick.jp

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
2015 Year 08 Month 25 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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 07 Day
Date of IRB
2015 Year 08 Month 20 Day
Anticipated trial start date
2015 Year 08 Month 25 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 25 Day
Last modified on
2020 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021743

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.