Unique ID issued by UMIN | UMIN000023890 |
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Receipt number | R000025803 |
Scientific Title | Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1) |
Date of disclosure of the study information | 2016/09/01 |
Last modified on | 2020/09/04 09:12:09 |
Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1)
PTCy and tacrolimus for GVHD prevention after allo-HCT from HLA matched donor (OCU16-1)
Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1)
PTCy and tacrolimus for GVHD prevention after allo-HCT from HLA matched donor (OCU16-1)
Japan |
Acute myeloid leukemia(AML)
Acute lymphoblastic leukemia(ALL)
Acute leukemias of ambiguous lineage
Myelodysplastic syndrome(MDS)
Chronic myeloid leukemia(CML)
Malignant lymphoma(ML)
Hematology and clinical oncology |
Malignancy
NO
Evaluation for safety and efficacy of PTCy and Tac for GVHD prevention of allo-HCT from HLA matched donor in Japan.
Safety,Efficacy
1 year chronic GVHD cumulative incidence
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Cy is intravenously administered at 50mg/kg/day on days 3 and 4. Continuous intravenous infusion of Tac is started at 0.03mg/kg/day from day 5. Unless GVHD developed, Tac was tapered from day 60-100 and stopped until day 180.
15 | years-old | <= |
70 | years-old | > |
Male and Female
(1) Disease
(a) AML
(b) ALL
(c) Acute leukemias of ambiguous lineage
(d) MDS
1. IPSS int-2 or high
2. Transfusion dependent MDS (more than 2 unit RBC or 10 unit platelet weekly transfusion)
(e) CML
1. CP beyond 1st CP
2. TKI failure in 1st CP
(f) malignant lymphoma
1. Indolent lymphoma after 1st relapse/progression
2. Aggressive lymphoma
*Chemo-refractory lymphoma after 1st relapse, or
*Lymphoma after 2nd relapse, or
*relapsed Lymphoma after auto-HCT
(g) a rare hematological malignancy except for (a)~(f) that was judged as necessity of allo-HCT in our conference
(2) Age >=15 and < 70 years old
(3) ECOG PS 0 or 1
(4) Normal function of major organs
(5) donor: presence of available sibling or unrelated donor with HLA-A, B, C, and DRB1 allele 8/8 match in GVH direction
(Note: no limitation for conditioning regimen intensity)
1) Major organ dysfunction
a) Total bilirubin:>= 2.0mg/dl
b) Serum creatinine: >= 2.0mg/dl
c) Ejection fraction: < 50 %
d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air
e) AST or ALT >= 3 x UNL
2) Uncontrolled active infection
3) Uncontrolled CNS invasion
4) Poorly controlled insulin-treated
diabetes mellitus
5) Poorly controlled hypertension
6) Patients with a severe complication including heart failure, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia
7) Pregnant, lactating or possible fertile women who may become pregnant
8) Patients with a severe mental who are likely to be unable to participate in the study
9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant
10) HIV antibody positivity
11) The administration of ATG is scheduled in conditioning regimen.
12) The physician in charge determines that there is no indication to perform this intervention.
(Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion.)
39
1st name | Hirohisa |
Middle name | |
Last name | Nakamae |
Osaka City University, Graduate School of Medicine
Hematology
545-8585
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan, 545-8585
06-6645-3881
hirohisa@msic.med.osaka-cu.ac.jp
1st name | Hirohisa |
Middle name | |
Last name | Nakamae |
Osaka City University, Graduate School of Medicine
Hematology
545-8585
1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan, 545-8585
06-6645-3881
crc-hematology@med.osaka-cu.ac.jp
Osaka City University
None
Self funding
Osaka City University Hospital Certified Review Board
1-2-7, Asahi-machi, Abeno-ku, Osaka, Japan, 545-0051
06-6645-3456
irb@med.osaka-cu.ac.jp
NO
2016 | Year | 09 | Month | 01 | Day |
Unpublished
No longer recruiting
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 07 | Month | 01 | Day |
2016 | Year | 10 | Month | 20 | Day |
2022 | Year | 07 | Month | 31 | Day |
2016 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025803
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