JPRN-jRCT2031180066Active, not recruitingPhase 1
Prospective study of Romiplostim for rapid platelet recovery after cord blood transplantation, phase 1 - PROMPT-1
Chiba Shigeru0 sites6 target enrollmentStarted: December 27, 2018Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 16age old to 65age old (—)
- Sex
- All
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
Investigators
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