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

Chiba Shigeru0 个研究点目标入组 6 人开始时间: 2018年12月27日最近更新: 2023年11月20日

试验速览

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•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

•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

发起方

Chiba Shigeru