UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hiroshi Matsuoka
Organization	Wakayama Medical University
Division name	Department of Hematology
Address	811-1, Kimiidera, Wakayama
TEL	+81-73-441-0665
Email	ketunai@wakayama-med.ac.jp

Public contact
Name of contact person	Hiroshi Matsuoka
Organization	Wakayama Medical University
Division name	Department of Hematology
Address	811-1, Kimiidera, Wakayama
TEL	+81-73-441-0665
Homepage URL
Email	ketunai@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 12 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031549