UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027522 |
|---|---|
| Receipt number | R000031549 |
| Scientific Title | A study of gemtuzumab ozogamicin in combination with G-CSF after CAG or MEC (CA-G-GO therapy or MEC-G-GO therapy) for relapsed or refractory acute myeloid leukemia. |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2017/05/29 09:24:20 |
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Basic information
Public title
A study of gemtuzumab ozogamicin in combination with G-CSF after CAG or MEC (CA-G-GO therapy or MEC-G-GO therapy) for relapsed or refractory acute myeloid leukemia.
Acronym
Phase II study of CA-G-GO or MEC-G-GO therapy for relapsed or refractory acute myeloid leukemia.
Scientific Title
A study of gemtuzumab ozogamicin in combination with G-CSF after CAG or MEC (CA-G-GO therapy or MEC-G-GO therapy) for relapsed or refractory acute myeloid leukemia.
Scientific Title:Acronym
Phase II study of CA-G-GO or MEC-G-GO therapy for relapsed or refractory 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
Evaluate efficacy and safety of CAG-G-GO or MEC-G-GO therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of complete remission
Key secondary outcomes
Safety profiles and grade, overall survival, event-free survival, disease-free survival, cytokine profiles and WT-1 mRNA
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
(CAG for aged 65 years or older)
After CAG therapy (cytarabine 10 mg/square meter/12h, sc, day1-10, aclarubicin 14 mg/square meter, div, day1-4, filgrastim 50 microgram/square meter, sc, day1-10), the same dose of filgrastim continues every day. When WBC count improves above 500/microliter, gemtuzumab ozogamicin (GO, 9 mg/square meter) is administered. 15 days after the first GO, the same dose of the second GO is administered.
(MEC for aged under 65 years)
24 hours after MEC therapy (mitoxantrone 3 mg/square meter, div, day1-6, etoposide 30 mg/square meter, div, day1-6, cytarabine 1g/square meter, div, day1-6), filgrastim (50 microgram/square meter, sc) starts and continues every day. When WBC count improves above 500/microliter, gemtuzumab ozogamicin (GO, 9 mg/square meter) is administered. 15 days after the first GO, the same dose of the second GO is administered.
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
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. CD33-positive AML with relapsed or refractory to induction therapy (except for APL)
2. written informed consent
3.PS 0-2 (ECOG)
4. no severe organ dysfunction
5. serum bilirubin is 2.0 mg/dL or less
6. serum creatinine is 1.5 mg/dL or less
Key exclusion criteria
1. Pregnant and/or lactating woman
2. History of hematopoietic stem cell transplantation
3. History of interstitial pneumonitis or ARDS
4. History of administration of GO
5. Uncontrolled infection
6. History of veno-occlusive disease
7. History of cardiac dysfunction induced by GO
8. Positive for HBV, HCV and HIV
9. MDS or AML derived from MDS
10. If physicians disagree to attend this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsuoka |
Organization
Wakayama Medical University
Division name
Department of Hematology
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
+81-73-441-0665
ketunai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsuoka |
Organization
Wakayama Medical University
Division name
Department of Hematology
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
+81-73-441-0665
Homepage URL
ketunai@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Center of Wakayama, Japanese Red Cross Society
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
和歌山県立医科大学 Wakayama Medical University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031549
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