UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020363 |
|---|---|
| Receipt number | R000023213 |
| Scientific Title | An investigator initiated phase II clinical trial of Tamibarotene (AM80G) for chronic graft-versus-host disease |
| Date of disclosure of the study information | 2015/12/27 |
| Last modified on | 2017/02/28 16:57:19 |
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Basic information
Public title
An investigator initiated phase II clinical trial of Tamibarotene (AM80G) for chronic graft-versus-host disease
Acronym
A phase II trial of Tamibarotene administration for Chronic GVHD
Scientific Title
An investigator initiated phase II clinical trial of Tamibarotene (AM80G) for chronic graft-versus-host disease
Scientific Title:Acronym
A phase II trial of Tamibarotene administration for Chronic GVHD
Region
| Japan |
Condition
Condition
Recipients refractory or resistant chronic GVHD to therapy with corticosteroid
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Tamibarotene (AM80G) for the patients of steroid-refractory chronic GVHD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Probability of failure-free survival (FFS) and complete/partial response at 24 weeks
Key secondary outcomes
1. Probability of FFS and complete/partial response at 12 weeks
2.Probability of FFS and overall survival rate at 1 year
3.Proportion of patients who are FFS and have at least 50% reduction in baseline steroid dose at 24 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were orally administered Tamibarotene (AM80G) (4 mg/day) daily for 24 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as chronic GVHD according to diagnostic criteria proposed by National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD.
1. Aged 18 to 84 years at consent
2. Patients with Karnofsky Performance Scale of 60 or more
3. Patient or guardian willing and able to provide informed consent
4. Steroid-refractory or steroid-resistant chronic GVHD defined as:
Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day or equivalent dose if on another steroid.
(1) Progression of chronic GVHD while being treated with prednisone therapy at a dose of greater than 1 mg/kg/day for 2 weeks.
(2) Failure to improve after 4 weeks while being treated with prednisone therapy at a dose of greater than 0.5 mg/kg/day for at least 2 weeks.
(3) Flare of chronic GVHD while tapering of steroids.
(4) steroid-dependent chronic GVHD received prednisone therapy at a dose of 10 mg/day or equivalent dose if on another steroid.
5. Stated willingness to use contraception during the study and through 2 years for wowen and 6 months for men after the final dose of study treatment.
Key exclusion criteria
1. Mental illness which needs psychiatric medication or are judged by physician as being unsuitable
2. Active, uncontrolled infection (not responding to antibiotics, antifungal or antiviral therapies)
3. Patients with severe liver dysfunction (CTCAE ver.4.0 Grade 3 or more, excepting liver GVHD)
4. Patients with previous experience with Am80 or other retinoid in the past 12 weeks
5. Patients who are allergic or hypersensitive to Am80 or other retinoid.
6. Patients who are pregnant, patients who have possibility of being pregnant, or patients who are breastfeeding.
7. Pulmonary: DLCO <40% or FEV1% <40%
8. Patients with life expectancy of less than 6 months.
9. Patients who are enrolled in other clinical studies in the past 3 months.
10. Other patients who are judged by physician as being unsuitable
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Maeda |
Organization
Okayama University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7227
yosmaeda@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisakazu Nishimori |
Organization
Okayama University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7227
Homepage URL
n-mori@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
岡山大学病院（岡山県）、安城更生病院（愛知県）、大阪市立大学病院（大阪府）、都立駒込病院（東京都）、九州大学病院（福岡県）、自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
Management information
Registered date
| 2015 | Year | 12 | Month | 27 | Day |
Last modified on
| 2017 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023213
