UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021553
Receipt number R000024460
Scientific Title CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia.
Date of disclosure of the study information 2016/03/21
Last modified on 2020/03/27 09:51:20

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Basic information

Public title

CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia.

Acronym

CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia(CA-GO2015).

Scientific Title

CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia.

Scientific Title:Acronym

CA-GO therapy for eldery patients with 1st relapsed or primary refractory CD33-positive acute myelogenous leukemia(CA-GO2015).

Region

Japan


Condition

Condition

CD33 positive, primary refractory or 1st relapse AML without APL.

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate efficacy and safety of CA-GO therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

CR rate on day43.

Key secondary outcomes

Rate of adverse events, OS, EFS, DFS, CR rate after 2nd CA-GO therapy, karyotype, WT1 mRNA, surface marker.


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

(CA-GO therapy)
Ara-C : 10mg/m^2/12h, sc, day1 - 14
ACR :
65 -69 years : 14mg/m^2/day
70 - years : 10mg/m^2/day
1 hour, div, day1 - 4(, 8 - 10)
GO(gemtuzumab ozogamicin) : 3mg/m^2/day, 2 hour, div, day15

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)CD33 positive, primary refractory or 1st relapse AML(non APL).
(2)Patient who has the registrar's written consent.
(3)PS 0, 1, 2
(4)T-B <2.0mg/dl
(5)Cre <2.0mg/dl
(6)PaO2 >60Torr or SpO2 >93%
(7)normal ECG and normal UCG(EF >50%)
(8)WBC <30,000 x10^6/L

Key exclusion criteria

(1)active other malignancy.
(2)cardiac infarction in one year.
(3)renal failure
(4)uncontrolable diabetes
(5)uncontrolable infection
(6)liver cirrhosis
(7)severe mental disorders
(8)pregnancy
(9)HIV positive
(10)allergy of GO
(11)recieved therapy include GO
(12)after SCT or solid organ transplantation

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Wataru
Middle name
Last name TAKAHASHI

Organization

Dokkyo medical university hospital

Division name

Hematology and Oncology

Zip code

321-0293

Address

880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi 321-0293, JAPAN

TEL

+81-282-86-1111

Email

twataru@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Wataru
Middle name
Last name TAKAHASHI

Organization

Dokkyo medical university hospital

Division name

Hematology and Oncology

Zip code

321-0293

Address

880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi 321-0293, JAPAN

TEL

+81-282-86-1111

Homepage URL


Email

twataru@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo medical university hospital, Hematology and Oncology

Institute

Department

Personal name



Funding Source

Organization

Dokkyo medical university hospital, Hematology and Oncology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Dokkyo University Hospital, Rinnsyou Kennkyuu Kanri Center

Address

880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi 321-0293, JAPAN

Tel

0282-87-2275

Email

r-kenkyu@dokkyomed.ac.jp


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

自治医科大学付属病院 血液科(栃木県)
自治医科大学付属さいたま医療センター 血液科(埼玉県)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 21 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

0

Results

not existed

Results date posted

2020 Year 03 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

not existed

Participant flow

not existed

Adverse events

not existed

Outcome measures

not existed

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 03 Month 21 Day

Date of IRB

2015 Year 06 Month 04 Day

Anticipated trial start date

2016 Year 03 Month 21 Day

Last follow-up date

2018 Year 03 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 03 Month 21 Day

Last modified on

2020 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024460


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name