UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018791 |
|---|---|
| Receipt number | 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 | 2023/06/09 06:17:29 |
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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
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
yuhonajima@cick.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
Institute
Department
Personal name
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
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
Completed
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
https://doi.org/10.1007/s00277-022-04981-x
Najima Y, Tachibana T, Takeda Y et al. Dose-finding trial of azacitidine as post-transplant maintenance for high-risk MDS: a KSGCT prospective study. Ann Hematol. 2022 Dec;101(12):2719-2729.
Management information
Registered date
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021743
