UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002603 |
|---|---|
| Receipt number | R000003176 |
| Scientific Title | Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia |
| Date of disclosure of the study information | 2009/10/13 |
| Last modified on | 2011/10/12 11:54:33 |
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Basic information
Public title
Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia
Acronym
JALSG GML208-P1
Scientific Title
Phase I study of Gemtuzumab Ozogamicin given in combination with Enocitabine and Daunorubicin as induction therapy for elderly patients with acute myeloid leukemia
Scientific Title:Acronym
JALSG GML208-P1
Region
| Japan |
Condition
Condition
acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety of gemtuzumab ozogamicin combined with BH-AC + DNR.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimation of maximum tolerated dose
Key secondary outcomes
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
Dose of GO(div day4) is determined at each level in combination with BH-AC(200mg/m2, day1-8) + DNR 30mg/m2, day1-3.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Firstly relapsed or primary refractory CD33-positive acute myeloid leukemia (excluding M3)
2) No history of GO treatment
3) ages, 65-74
4) PS, 0-1
5) AST, ALT < 2.5-fold of upper limit of each institute
6) Total bilillubin < 1.5 mg/dL
7) Serum creatinine < 2.0 mg/dL
8) No ischmic sign or arrythmia to be treated on ECG
9 Left ventricular ejection fraction > 50%
10) PaO2 > 65mmHg or SaO2 > 93% (room air)
11) Expected to survive more than two months
12) Written consent after careful information including insufficient experience in our country
Key exclusion criteria
1) History of myelodysplastic syndromes or myeloproliferative neoplasms
2) Therapy-related leukemia
3) Infiltration on central nurvous system
4) Previous autologous or allogeneic stem cell transplantation
5) History of glaucoma
6) Diabetes mellitus currently treated with insulin
7) Uncontrollable hypertension
8) History of ischemic heart disease, cardiomyopathy or arrythmia currently treated
9) Interstitial pneumonia, pulmonary fibrosis, or svere emphysema
10) Positivity of HBs antigen, HCV antibody or human immunodeficiency virus
11) Active infectious disease
12) Liver cirrhosis
13) Double cancer
14) Difficulty of treatment based on mental illness
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ito |
Organization
Tokyo Medical University
Division name
Hematology Division
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical University
Division name
Hematology Division
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Adult Leukemia Study Group
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
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
| 2009 | Year | 10 | Month | 13 | 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
| 2008 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2011 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003176
