Unique ID issued by UMIN | UMIN000005662 |
---|---|
Receipt number | R000006693 |
Scientific Title | Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome |
Date of disclosure of the study information | 2011/05/30 |
Last modified on | 2018/07/27 14:45:34 |
Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome
Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome
Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome
Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome
Japan |
low-risk myelodysplastic syndrome
Hematology and clinical oncology |
Malignancy
NO
The aime of this study is to analyze the efficacy and safety of 5-day regimen of azacitidine in patients with low-risk MDS (RA, RARS) and to evaluate the changes of various clinical markers.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
hematological improvement
1. hematological remission
2. transfusion dependency
3. hematological improvement in each chromosomal karyotype
4. progression stage (WT1)
5. continuity of therapy
6. adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The dosage is 75mg/m2 of azacitidine by subcutaneous injection or intravenous infusion for 10 minutes once daily for 7 days every four weeks.
20 | years-old | <= |
Not applicable |
Male and Female
1.Patients with low risk MDS (RA, RARS) according to FAB classification and is considered by investigator to be adequate for this study, meeting at least one of three following criteria.
i) a packed red blood cell transfusion history in 3 months (12 weeks) prior to the enrollment
ii) platelet count less than 50,000/mm3 or clinically meaningful bleeding symptoms
iii) neutrophil count less than 1,000/mm3 and increased susceptibility to infection (requiring use of antibiotics)
2. Patients with a life expectancy of at least 3 months at the time of enrollment
3. Patients with no prior administration of azacitidine-based treatment (Chemotherapy, HSCT, Lenalidomide, Imuunosuppressive therapy, Anabolic steroids therapy, Iron-chelation therapy, Vitamin D and Vitamin K are allowed)
4. Age: 20 years and over
5. Patients who is not planned for allo-HSCT.
6. Patients with ECOG performance status of 0-2
7. Patients with clinically adequate hepatic, renal and heart function defined as follows
i) Serum total bilirubin less than 2.0 mg/dl
ii) Serum creatinine less than 2.0 mg/dl
iii) PaO2 more than 60 Torr or SaO2 more than 93% while breathing room air.
iv) no severe ECG abnormalities.
8. Patients who can be hospitalized during at least 1st cycle.
9. Patients who has given a written informed consent for this study (including contraception).
1. Patients with simultaneous multiple cancers.
2. Patients with history of hyper- sensitivity to mannitol
3. Patients with poorly-controlled infection requiring intensive care with antibiotics and antifungals.
4. Patients with poorly-controlled diabetes.
5. Patients with severe psychiatric disorder.
6. Pregnant or lactating females.
7. Patients with positive serology for HBs antigen, HCV antibody or HIV antibody.
8. Patients who is deemed as ineligible for this study by investigator.
50
1st name | |
Middle name | |
Last name | Mitsuhiro Matsuda, MD, PhD |
PL General Hospital
Department of Hematology
2204 Shindo, Tondabayashi, Osaka 584-8585
0721-23-7805
1st name | |
Middle name | |
Last name | Mitsuhiro Matsuda, MD, PhD |
PL General Hospital
Department of Hematology
2204 Shindo, Tondabayashi, Osaka 584-8585
0721-23-7805
matsuda@plhospital.or.jp
Department of Hematology, Kinki University School of Medicine
none
Self funding
NO
2011 | Year | 05 | Month | 30 | Day |
Published
Completed
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 01 | Day |
2016 | Year | 05 | Month | 31 | Day |
2018 | Year | 04 | Month | 07 | Day |
2011 | Year | 05 | Month | 27 | Day |
2018 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006693