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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021553
Receipt No. 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 2016/11/03

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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
Middle name
Last name Wataru Takahashi
Organization Dokkyo medical university hospital
Division name Hematology and Oncology
Zip code
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
Middle name
Last name Wataru Takahashi
Organization Dokkyo medical university hospital
Division name Hematology and Oncology
Zip code
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
Institute Dokkyo medical university hospital, Hematology and Oncology
Institute
Department

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
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 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
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
2016 Year 03 Month 21 Day
Date of IRB
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
2016 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.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


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