Prospective study of Romiplostim for rapid platelet recovery after cord blood transplantation, phase 1

Phase 1

• Conditions: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), no

• Registration Number: JPRN-jRCT2031180066
• Lead Sponsor: Chiba Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-27
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Preliminary inclusion criteria

1) Patients with AML (blast < 5%), ALL (blast < 5%), MDS (blast < 5%), or NHL (complete response or partial response)
2) Patients 16 to 65 years of age
3) Patients who do not have HLA antigen-matched (6/6) appropriate related donors
4) Patients who do not have HLA allele-matched (8/8) unrelated donors.
5) Patients with ECOG of 0, 1, or 2
6) Patients without severe dysfunction in the heart, the lung, the liver, and the kidney
(a) ejection fraction >= 40%
(b) SaO2 (or SpO2) >= 94%
(c) %VC >= 70%, and FEV1.0% >= 70%
(d) total bilirubin < x1.5 of the upper limit
(e) ALT < x3 of the upper limit
(f) AST < x3 of the upper limit
(g) creatinine < 2.0 mg/dL
7) Patients who gave written informed consent

2. Secondary inclusion criteria
1) SaO2 (or SpO2) >= 94%
2) total bilirubin < x1.5 of the upper limit
3) ALT < x3 of the upper limit
4) AST < x3 of the upper limit
5) creatinine < 2.0 mg/d

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