UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001141 |
|---|---|
| Receipt number | 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 16:00:38 |
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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
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/
usuin@jikei.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001385
