Unique ID issued by UMIN | UMIN000010697 |
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Receipt number | R000012502 |
Scientific Title | A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF. |
Date of disclosure of the study information | 2013/05/12 |
Last modified on | 2018/03/21 15:21:57 |
A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF.
JSCT-FB13 PB/BM
A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF.
JSCT-FB13 PB/BM
Japan |
AML,MDS
Hematology and clinical oncology |
Malignancy
NO
To investigate safety and efficacy of HLA matched related bone marrow or peripheral blood stem cell transplantation using 180mg/m2 of fludarabine, 12.8mg/kg of intravenous busulfan, cytarabine and G-CSF for elderly patients aged 55-70 with AML or MDS.
Efficacy
Event-free survival at 1 year after transplantation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Conditioning regimen:
G-CSF day-8--day2 200µg/m2+ Cytarabine day-7-day-4 100mg/m2+Flu 180mg/m2 + ivBu 12.8mg/kg + TBI 2Gy X 2
GVHD prophylaxis:
tacrolimus + oral mycophenolate mofetil (MMF)(30mg/kg/day in two divided doses, from day -1 to 30, and subsequently tapered and discontinued within 2 weeks, privided that there is no active GVHD requiring treatment)
55 | years-old | <= |
70 | years-old | >= |
Male and Female
1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation.
2. Age: 15-65 years old.
3. 2nd CR or subsequent CR, non CR.
1st CR as defined at least one of the following:
a) Acute lymphoblastic leukemia
Poor risk as defined by NCCN guidelines
b) Acute Myelogenous Leukemia
Greater than 1 cycle of induction therapy required to achieve remission
High risk as defined by NCCN guidelines
Monosomal karyotype
ckit mutations with t(8;21), inv(16), t(16;16)
t(7;11)(p15;p15)
Preceding myelodysplastic syndrome
c) Myelodysplastic syndrome
high, very high as defined by WHO classification-based Prognostic Scoring System
Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month.
4. Performance status: 0-2
5.Those who have available donors(HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM
6.Those who have no severe organ dysfunction (T. Bil<2.0mg/ml, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%)
7.Those who give written informed consent following sufficient explanation.
8.Those who are evaluated to be able to survive more than 3 months.
1.Those who are positive for anti-HIV antibody
2.Those who have history of gemtuzumab ozogamicin (MylotargTM) use within 4 months
3.Those who have coinciding active malignancies
4.Those who have uncontrolled psychiatric disorder
5.Those who have active infection
30
1st name | |
Middle name | |
Last name | Naoya Uchida |
Toranomon Hospital, Tokyo, Japan
Department of Hematology
2-2-2,Toranomonn,Minato-ku,Tokyo,Japan
1st name | |
Middle name | |
Last name |
JSCT
FB10 datacenter
jsct-office@umin.ac.jp
JSCT
Resarch Foundation for Community Medicine
Non profit foundation
NO
2013 | Year | 05 | Month | 12 | Day |
Published
Main results already published
2013 | Year | 04 | Month | 27 | Day |
2013 | Year | 05 | Month | 13 | Day |
2017 | Year | 08 | Month | 26 | Day |
2013 | Year | 05 | Month | 12 | Day |
2018 | Year | 03 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012502
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