A phase II study to reveal safety and efficacy of TM5509 in cord blood transplantation - TM5509-4

Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata0 sites21 target enrollmentJuly 10, 2015

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cord Blood Transplantation
Sponsor: Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata
Enrollment: 21
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

July 10, 2015

End Date

December 31, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata

•(1\) History of ICH (2\) Un\-controrable infection (3\) Un\-controrable hypertension (4\) Known active chronic hepatitis B (HBs Ag\+) or C (HCV Ab\+) (5\) Liver disfunction; T\-Bil, AST, ALT, gGTP or ALP \> 2x upper limit of normal range (6\) Renal failure; GFR less than 50ml/min (7\) Sever complication with cardiovascular, pulmonary or gastrointestinal system (8\) Plural of cancer (9\) High titer of anti HLA antibody against donor specific HLA (10\) Under using Pentostatin (11\) Known hemolytic anemia by Fludarabine (12\) Porphyria (13\) Known allergy against Fludarabine, Melphalan, Methylprednisolone, Hydroxyzine, Cetirizine, Piperazinederivative, Aminophylline or Ethylenediamine (14\) Male patients who do not agree with contraception during the study period. (15\) Candidate mother, lactation or hope for pregnancy while the study period (16\) Patient who had registered and medicated in the other clinical trial within 12 weeks before consent. (17\) Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.