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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name