Unique ID issued by UMIN | UMIN000007281 |
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Receipt number | R000008514 |
Scientific Title | Safety and efficacy of reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies |
Date of disclosure of the study information | 2012/02/13 |
Last modified on | 2014/02/06 11:47:53 |
Safety and efficacy of reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies
GHSG-SCT1101
Safety and efficacy of reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies
GHSG-SCT1101
Japan |
Acute myeloid leukemia(AML), Myelodysplastic syndrome(MDS), Acute lymphoblastic leukemia(ALL), Malignant lymphoma(ML), chronic myeloid leukemia(CML)
Hematology and clinical oncology |
Malignancy
NO
The purpose of this study is to investigate the safety and efficacy of related and unrelated bone marrow or peripheral blood stem cell transplantation, or cord blood transplantation using reduced intensity myeloablative conditioning regimen with fludarabine, cytarabine arabinoside, and cyclophosphamide for hematological malignancies who is ineligible for conventional myeloablative regimen due to high age between 55 and 70 years or even aged 20 - 55 years with significant comorbidity.
Safety,Efficacy
Donor cell engraftment rate and survival rate at 60 days after transplantation
1) Completion rate of conditioning regimen and protocol
2) Incidence of grade 3 or higher adverse events within 60 days after transplantation
3) Achievement rate of complete donor chimaerism within 100 days after transplantation
4) Non-relapse mortality within 100 days after transplantation
5) Incidence of infection within 1 year after transplantation
6) Incidence and severity of chronic GVHD within 1 year and 2 years after transplantation
7) Relapse rate within 1 year and 2 years after transplantation
8) Disease free survival within 1 year and 2 years after transplantation
9) Overall survival within 1 year and 2 years after transplantation
10) Subgroup analysis of donor source
11) Subgroup analysis of underlying disease
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Conditioning regimen
1) HLA matched related BM or PBSC donor
Fludarabine (Flu) 150mg/m2 + Cytarabine arabinoside (AraC) 8-16g/m2 + Cyclophosphamide (Cy) 50mg/kg
2) HLA mismatched related BM or PBSC donor and unrelated BM donor
Flu 150mg/m2 + AraC 8-16g/m2 + Cy 50mg/kg +- TBI 2Gy
3) Cord blood
Flu 150mg/m2 + AraC 8-16g/m2 + Cy 50mg/kg +- TBI 2Gy x2
GVHD prophylaxis:
1) HLA matched related BM or PBSC donor
Cyclosporine + short-term methotrexate(MTX)(day 1: 10mg/m2, day 3, 6: 7mg/ m2)
2) HLA mismatched related BM or PBSC donor and unrelated BM donor
Tacrolimus + short-term MTX(day 1: 10mg/m2, day 3, 6, 11: 7mg/m2, administration of MTX on day11 may be omitted by each physician's decision.)
3) Cord blood
Cyclosporine + short-term MTX(day 1: 10mg/m2, day 3, 6: 7mg/m2)
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1)Patients diagnosed as hematological malignancies who meet the following conditions,
a)AML
1.AML in advanced stage beyond CR1, received more than one course of chemotherapy to achieve CR, in high risk disease category according to SWOG/ECOG criteria, or in non-CR including relapse after auto or allo-SCT.
2.AML who have less than 30% bone marrow blasts at the registration.
b)MDS in poor prognosis group with WPSS high or very high, relapse after remission (including transplantation), or required platelet or red cell transfusions)
b)ALL
1.ALL in CR1 with a poor prognostic factor, in >=CR2, received more than one course of chemotherapy to achieve CR, in non-CR including relapse after auto or allo-SCT, or Ph+ALL in CR1 without achievement of MR.
2.ALL who have less than 30% bone marrow blasts at the registration.
d) ML
1.One of the following type of the histological type (WHO classification)
Precursor B- and T-cell neoplasms
Mature B-cell neoplasms
Mature T-cell and NK-cell neoplasms
Hodgkin lymphoma
2.ML who did not achieve PR after first-line chemotherapy, first relapsed ML who did not achieve PR after first-line salvage therapy , second relapsed ML, or in non-CR including relapse after auto-PBSCT.
e)CML
1.CML in CP with resistance to TKI or the T315I mutation, second or subsequent CP, AP, BP, or relapsed in non-CP including relapse after auto or allo-SCT.
2.CML who have less than 30 % bone marrow blasts at the registration.
2)Aged from 55 to 70 years old or aged from 20 to 55 years old with significant comorbidity.
3)Patients who have available donors (HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM, less than 2 antigen-mismatched CB with more than 2x10^7/kg)
4)ECOG performance status 0-2
5)Patients who have no severe organ dysfunction (T.Bil<2.0mg/dl, AST, ALT<=2.5xULN, Cr<2.0mg/dl, EF>50%, SpO2>95%)
6)Patients who give a written informed consent
7)Patients who are evaluated to be able to survive more than 3 months
1) Patients with HIV
2) Patients who received gemtuzumab ozogamicin within 3 months
3) Patients with another active malignancy
4) Patients with severe mental disease
5) Patients with severe central nervous system (CNS) lesions (except for CNS lesions of the underlying disease)
6) Patients with active infection
7) Patients who have history of chemotherapy within 21 days before transplantation (except hydroxyurea, cytarabine, or etoposide therapy for blast control)
8) Patients who have hypersensitivity to drugs included in this protocol
9) Patients who are judged inappropriate for the entry into the study by the principle doctor.
36
1st name | |
Middle name | |
Last name | Hisashi Tsurumi |
Gifu University Hospital
First Department of Internal Medicine
1-1 Yanagido Gifu
058-230-6000
htsuru@gifu-u.ac.jp
1st name | |
Middle name | |
Last name | Nobuhiro Kanemura |
Gifu University Hospital
First Department of Internal Medicine
1-1 Yanagido Gifu
058-230-6008
nkane@orion.ocn.ne.jp
Gifu University Hospital
Gifu University Hospital First Department of Internal Medicine
Self funding
NO
岐阜大学医学部附属病院(岐阜県)
岐阜市民病院(岐阜県)
岐阜赤十字病院(岐阜県)
2012 | Year | 02 | Month | 13 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 20 | Day |
2011 | Year | 04 | Month | 01 | Day |
2012 | Year | 02 | Month | 13 | Day |
2014 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008514
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