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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033799
Receipt No. 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 2018/08/23

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Basic information
Public title Prospective study of ROMiplostim for rapid Platelet recovery after cord blood Transplantation, phase 1
Acronym PROMPT-1
Scientific Title Prospective study of ROMiplostim for rapid Platelet recovery after cord blood Transplantation, phase 1
Scientific Title:Acronym PROMPT-1
Region
Japan

Condition
Condition acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), non-Hodgkin lymphoma (NHL)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety of AMG531 administration after cord blood transplantation by phase I trial.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Every adverse event which is related to administration of AMG531
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of AMG531 every week after cord blood transplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key 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/dL
Key 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
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Chiba
Organization University of Tsukuba Hospital
Division name Department of Hematology
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3127
Email schiba-t@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Kurita
Organization University of Tsukuba Hospital
Division name Department of Hematology
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3127
Homepage URL
Email schiba-t@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 18 Day
Last modified on
2018 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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