UMIN-CTR Clinical Trial

Public title

A Phase II/III trial of JR-031 for the treatment of steroid-refractory acute Graft-versus-Host disease after hematopoietic stem cell transplantion

Acronym

Phase II/III trial of JR-031

Scientific Title

A Phase II/III trial of JR-031 for the treatment of steroid-refractory acute Graft-versus-Host disease after hematopoietic stem cell transplantion

Scientific Title:Acronym

Phase II/III trial of JR-031

Region

Japan

Condition

Steroid-refractory acute Graft-versus-Host disease

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm an efficacy and safety of JR-031 administered to the patients who are diagnosed with Grade III-IV steroid-refractory acute GVHD after hematopoietic stem cell transplantation (Bone Marrow transplantation, peripheral blood stem cell transplantation, umbilical cord blood transplantation)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II,III

Primary outcomes

Complete Response which is durable response for 28 consecutive days or more during the period of 24 weeks after the first infusion.

Key secondary outcomes

Overall response (OR; CR(Complete Response) or PR(Partial Response)) at the timepoint of 4 weeks after the first infusion.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

JR-031 is administered 8 times (twice per week for 4 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

Age-lower limit

6

months-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) A patient who is diagnosed with steroid-refractory acute GVHD (which means refractory to either standard therapy according to the guideline of The Japan Society for Hematopoietic Stem Cell Transplantation or steroid pulse therapy), and severity of grade III-IV at the first infusion.
2) A patient aged 6 months or over.
3) A patient who can understand the contents of this trial and can consent voluntarily.

Key exclusion criteria

1) A patient who have already received treatments of any other medications than standard steroid therapy for acute GVHD, except steroid pulse therapy or the prophylactic medications which proceed before the onset of acute GVHD.
2) A patient who has received hematopoietic stem cell transplantation and not in remission of his/her underlying hematopoietic malignancy. (Patients in remission with low risk of early recurrence as predicted by the principal investigator or clinical investigators, are excluded.
3) A patient who has allergy to bovine and/or porcine products.
4) A patient who has severe, uncontrollable infection, such as sepsis.
5) A patient who has highly cardiac dysfunction, pulmonary dysfunction, renal dysfunction or any other hepatic dysfunction than GVHD symptom.
6) A patient who is pregnant or expected or breast-feeding.
7) A patient who is diagnosed with HIV antibody positive, HTLV-I antibody positive, HBs antigen positive or HCV antibody positive, except the HCV antibody positive patient who is diagnosed with HCV-RNA negative, or the HTLV-I antibody positive patient whose underlying disease is ATL.
8) A patient who is diagnosed with uncontorablle hypertension despite treatments.
9) A patient whose PSaO2 is under 94% despite an oxygen administration.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Keiya Ozawa

Organization

Jichi Medical University Hospital

Division name

Division of Hematology

Zip code

Address

3311-1 Yakushi-ji, Shimotsuke-shi, Tochigi, 329-0498, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

JCR pharmaceuticals Co., Ltd.

Division name

Development div.

Zip code

Address

2-4 Kasuga-cho, Ashiya 659-0021 Japan

TEL

0797-32-8582

Homepage URL

Email

Institute

JCR pharmaceuticals Co., Ltd.

Institute

Department

Personal name

Organization

JCR pharmaceuticals Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

08

Month

26

Day

Date of IRB

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

11

Month

14

Day

Last modified on

2014

Year

06

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007942