Prospective study of ROMiplostim for rapid Platelet recovery after cord blood Transplantation, phase 1

Not Applicable

• Conditions: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), non-Hodgkin lymphoma (NHL)

• Registration Number: JPRN-UMIN000033799
• Lead Sponsor: niversity of Tsukuba Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-23
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

1. Preliminary exclusion criteria 1) Patients with anti-HLA antibody 2) Patients with uncontrollable psychological complications 3) Patients with active double cancer 4) Patients with uncontrollable active infection 5) Patients with bone marrow fibrosis (reticulin grade >= 2) 6) Patients with prior history of allogeneic hematopoietic transplantation 7) Patients with severe cardiac complications 8) Patient with prior thrombotic history or with predisposing factors to thrombosis 9) Patients with positive for HIV antibody, HBs antigen, or HCV-RNA 10) Patients with uncontrollable diabetes mellitus 11) Patients with uncontrollable hypertension 12) Patients who were enrolled to other clinical trials within 3 months 13) Patients with prior history of TPO-R administration 14) Patients with hypersensitivity to recombinant protein derived from E-coli 15) Pregnant women, patients during lactation, or patients who deny anticonception 16) Patients who are judged inappropriate by investigators 2. Secondary exclusion criteria 1) Patients who are judged inappropriate by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified