Unique ID issued by UMIN | UMIN000033799 |
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Receipt number | R000038560 |
Scientific Title | Prospective study of ROMiplostim for rapid Platelet recovery after cord blood Transplantation, phase 1 |
Date of disclosure of the study information | 2018/08/23 |
Last modified on | 2023/08/22 10:26:21 |
Prospective study of ROMiplostim for rapid Platelet recovery after cord blood Transplantation, phase 1
PROMPT-1
Prospective study of ROMiplostim for rapid Platelet recovery after cord blood Transplantation, phase 1
PROMPT-1
Japan |
acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), non-Hodgkin lymphoma (NHL)
Hematology and clinical oncology |
Malignancy
NO
To evaluate safety of AMG531 administration after cord blood transplantation by phase I trial.
Safety
Every adverse event which is related to administration of AMG531
cumulative incidence of cases which achieved platelet >= 50,000 /mcL by day 57
day of neutrophil engraftment
day of platelet >= 20,000 /mcL
day of platelet >= 50,000 /mcL
total amount of transfused platelet units
hemorrhagic events
thrombotic events
fibrosis of the bone marrow
disease relapse
non-relapse mortality
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of AMG531 every week after cord blood transplantation
16 | years-old | <= |
65 | years-old | >= |
Male and Female
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/dL
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
6
1st name | Chiba |
Middle name | |
Last name | Shigeru |
University of Tsukuba Hospital
Department of Hematology
3058575
2-1-1 Amakubo, Tsukuba, Ibaraki
029-853-3127
schiba-t@md.tsukuba.ac.jp
1st name | Kurita |
Middle name | |
Last name | Naoki |
University of Tsukuba Hospital
Department of Hematology
305-8575
2-1-1 Amakubo, Tsukuba, Ibaraki
029-853-3127
schiba-t@md.tsukuba.ac.jp
University of Tsukuba Hospital
None
Other
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NO
2018 | Year | 08 | Month | 23 | Day |
Unpublished
Completed
2018 | Year | 06 | Month | 22 | Day |
2020 | Year | 01 | Month | 27 | Day |
2018 | Year | 01 | Month | 27 | Day |
2021 | Year | 12 | Month | 31 | Day |
2018 | Year | 08 | Month | 18 | Day |
2023 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038560
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