Phase III Clinigal Study of ME3208 in Patients with cGVHD
- Conditions
- Chronic graft versus host disease
- Registration Number
- JPRN-jRCT2011210041
- Lead Sponsor
- Kijima Koji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1) Patients who are able to provide written informed consent
2) Patients who received allogeneic hematopoietic cell transplantation (aHCT)
3) Patients diagnosed with moderate to severe chronic GVHD
4) Patients defined as steroid-dependent/refractory chronic GVHD at any time point after aHCT
5) Patients with the performance scale of 60 or more at baseline
1) Patients with active acute GVHD
2) Patients with post-transplant lymphoproliferative disease
3) Patients with a severe past history or complications (malabsorption syndrome, poorly controlled psychiatric disease, coronary artery disease, etc.) that may affect the evaluation of this study as judged by the principal investigator or subinvestigator
4) Patients who cannot maintain medication adherence as judged by the principal investigator or subinvestigator
5) Patients for whom the principal investigator or subinvestigator judged that the implementation of this study is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: best overall response rate (best ORR) [Percentage of participants who achieve complete response (CR) or partial response (PR)]<br>Safety: The safety are assessed by subjective symptoms, objective findings, physiological and clinical examinations.
- Secondary Outcome Measures
Name Time Method The efficacy of ME3208 are evaluated using duration of response (DOR), best ORR by organ and time point, time to response (TTR) , etc. as secondary outcomes.<br>Evaluate the pharmacokinetics after administration of ME3208.