UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033799
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

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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 Chiba
Middle name
Last name Shigeru

Organization

University of Tsukuba Hospital

Division name

Department of Hematology

Zip code

3058575

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 Kurita
Middle name
Last name Naoki

Organization

University of Tsukuba Hospital

Division name

Department of Hematology

Zip code

305-8575

Address

2-1-1 Amakubo, Tsukuba, Ibaraki

TEL

029-853-3127

Homepage URL


Email

schiba-t@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba Hospital

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2018 Year 06 Month 22 Day

Date of IRB

2020 Year 01 Month 27 Day

Anticipated trial start date

2018 Year 01 Month 27 Day

Last follow-up date

2021 Year 12 Month 31 Day

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

2023 Year 08 Month 22 Day



Link to view the page

Value
https://center6.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