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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001141
Receipt No. R000001385
Scientific Title Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
Date of disclosure of the study information 2008/05/10
Last modified on 2011/10/31

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Basic information
Public title Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
Acronym Phase I Study of GO+Ara-C+DNR for Relapsed or Refractory Patients with Acute Myeloid Leukemia
Scientific Title Phase I Study of gemtuzumab ozogamicin in combination with cytarabinne and daunorubicin as induction therapy for relapsed or refractory patients with acute myeloid leukemia.
Scientific Title:Acronym Phase I Study of GO+Ara-C+DNR for Relapsed or Refractory Patients with Acute Myeloid Leukemia
Region
Japan

Condition
Condition Acute Myeloid Leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of safety and recommended schedule of combination chemotherapy with GO and conventional antiluekemic drugs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Dose limiting toxicity(DLT) ,maximum tolerated dose(MTD) and optimal dose and schedule of DNR and GO
Key secondary outcomes Rates of complete remission and safety profile and grades.

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 Combination chemotherapy of Gemtuzumab ozogamicin+Daunorubicin+Cytarabine as induction therapy
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.CD33-positive AML with first relapsed (CR duration>6 months) or refractory to initial induction therapy (exclusion of APL)
2.Age; above 20 to younger than 65 years old
3.PS 0-2 (ECOG)
4.More than 30 days after previous therapy
5. Adequate hepatic, renal, pulmonary and cardiac function
serum bilirubin <1.5 mg/dL, serum creatinine <2.0 mg/dL,PaO2>60 mmHg or SaO2>93%, ECG: WNL
6.More than 2 months of life expectancy
7. Written informed consent
Key exclusion criteria 1. History of MDS or MPD
2. Secondary AML related to chemotherapy or radiotherapy
3. CNS-leukemia
4. History of hematopoietic stem cell transplantation
5. Total dose of DNR >500 mg/m2
6. Pregnant and/or lactating woman
7. History of therapy with anti-CD33 monoclonal antibody
8. Complication of active malignant disease
9. Uncontrolled infection
10.Positive HBV, HCV and HIV infection
11.History of attending any phase study of new drugs.
12.If physisians disagree to attend this study
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Usui
Organization Department of Clinical Oncology and Hematology
Division name Department of Clinical Oncology and Hematology
Zip code
Address 4-11-1,Izumi-honcho,Komae-shi,Tokyo
TEL 03-3480-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Usui
Organization The Jikei University School of Medicine(Dai-San Hospital)
Division name Department of Clinical Oncology and Hematology
Zip code
Address 4-11-1,Izumi-honcho,Komae-shi,Tokyo
TEL 03-3480-1151
Homepage URL http://www.jalsg.jp/
Email usuin@jikei.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
2008 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21585619
Number of participants that the trial has enrolled
Results
Three patients in the IAG regimen who were administered 5 mg/m(2) GO showed DLT. No patients had veno-occlusive disease or sinusoidal obstructive syndrome. In conclusion, 3 mg/m(2) GO combined with Ara-C and IDR or DNR can be safely administered, and phase II trials should be conducted to investigate the clinical efficacy of the combination therapy.
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
2006 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2011 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 30 Day
Last modified on
2011 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001385

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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