Unique ID issued by UMIN | UMIN000023548 |
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Receipt number | R000027122 |
Scientific Title | Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial) |
Date of disclosure of the study information | 2016/08/09 |
Last modified on | 2017/02/01 21:00:06 |
Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial)
HLA fully mismatched hematopietic stem cell transplantation
Hematopoietic stem cell transplantation from HLA fully mismatched family members for post-transplant relapse/rejection (phase I/II trial)
HLA fully mismatched hematopietic stem cell transplantation
Japan |
hematologic malignancies relapesd/rejected after allogeneic stem cell transplantation
Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety and efficacy of stem cell transplantation from HLA fully mismatched family members for hematologic malignancies relapsed or rejected after allogeneic transplantation
Safety,Efficacy
Exploratory
Phase I,II
Rate of donor cell engraftment (defined as Neutrophil >500/microL with >90% of donor origin) on day 35
a) Incidence and severity of chronic GVHD
b) transplantion-associated complications, including TMA
c) survival rate
d) relapse rate
e) other adverse effects (CTCAE)
within three months
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
The basic structure of the preconditioning regimen consists of fludarabine (FLU) at 30 mg/m2/day for 6 days (days -9 and -4), melphalan (MEL) at 70 mg/ m2/day for 2 days (days -3 and -2), and rabbit anti-thymocyte globulin (ATG, Thymoglobulin, Sanofi) at 1.25 mg/kg/day for 2 days (days -2 and -1). To ensure engraftment, 3 Gy of total body irradiation (TBI) was added. For active diseases, high-dose cytarabine (CA) at 2 g/m2/day for 4 days (days -9 and -6) was added for the purpose of tumor reduction. To prevent anaphylaxis caused by ATG, methylprednisolone (mPSL) was administered at 2 mg/kg on days -2 and -1. GVHD prophylaxis consists of the continuous infusion of TAC with a target concentration of 10-12 ng/mL started from day -3, 1 mg/kg/day of mPSL started after day 0, and 15 mg/kg/day of MMF started from day 3 (Table 1). Peripheral blood stem cells (PBSC) were used as a stem cell source, which were infused without being frozen. G-CSF was administered from day 3 to the day of engraftment.
Not applicable |
Not applicable |
Male and Female
Patients with hematologic malignancies relapsed or rejected after allogeneic stem cell transplantation who fulfill the following (patient and donor),
[patient]
1) Written informed consent
2) no expectancy of cure with standard therapies including DLI
[donor]
1) healthy spouse who desires to become the donor
2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by the conference)
1) Cre > 2.0 mg/dl
2) EF < 40%
3) T-Bil > 2.0 mg/dl
4) AST and/or ALT > 200 U/L
5) SpO2 < 90% (room air)
6) PS (ECOG score) 3-4
Patients with data due to original disease are not excluded.
20
1st name | |
Middle name | |
Last name | Hiroyasu Ogawa |
Hyogo College of Medicine
Division of Hematology, Department of Internal Medicine
1-1, Mukogawa-cho, Nishinomiya city, Hyogo
+81-798-45-6886
haplo@hyo-med.a.cjp
1st name | |
Middle name | |
Last name | Kazuhiro Ikegame |
Hyogo College of Medicine
Division of Hematology, Department of Internal Medicine
1-1, Mukogawa-cho, Nishinomiya city, Hyogo
+81-798-45-6886
kame@hyo-med.ac.jp
Hyogo College of Medicine
Ministry of Education, Culture, Science and Technology
Japanese Governmental office
NO
2016 | Year | 08 | Month | 09 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 08 | Month | 08 | Day |
2016 | Year | 08 | Month | 09 | Day |
2016 | Year | 08 | Month | 08 | Day |
2017 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027122
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