Unique ID issued by UMIN | UMIN000003942 |
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Receipt number | R000004725 |
Scientific Title | Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for elderly patients with hematological malignancies: A phase I/II study |
Date of disclosure of the study information | 2010/09/01 |
Last modified on | 2016/07/28 07:37:21 |
Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study
Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study
Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study
Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for
elderly patients with hematological malignancies: A phase I/II study
Japan |
1. Acute lymphoblastic leukemia with or without Philadelphia chromosome: any CR or non-CR with marrow blasts <50%.
2. Acute myeloid leukemia: any CR or non-CR with marrow blasts <50%.
3. Myelodysplastic syndrome: IPSS intermediate-II or high. Relapse after remission.
4. Malignant lymphoma
1) Indolent lymphoma (including Mantle cell lymphoma): Chemo refractory case
2) Aggressive lymphoma: PR1, >CR1, or good PR.
3) Highly aggressive lymphoma: any CR or good PR.
Hematology and clinical oncology |
Malignancy
NO
To test the safety, and efficacy of Fludarabin and TBI combination for myeloablative conditioning for elderly patients with hematological malignancies (phase I/II study).
Safety,Efficacy
Non-hematological toxicities within 35days after HSCT(Phase I part).
One-year disease free survival rate (PhaseII part).
Graft failure
Regimen related toxicity (RRT)
Acute GvHD incidence and severity
Relapse
Non relapse mortality
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Flu 30mg/m2x4days+Total body irradiaition(TBI)for conditioning. Dose escalation study every 6 doses from 8Gy of TBI.
18 | years-old | <= |
65 | years-old | > |
Male and Female
1.Age: 55 to 65 years, or 18 to 55years not indicate for myeloablative conditioning due to complications such as past infection.
2.HLA matched or 1 Ag mismatched relate or unrelated donor.
3.ECOG 0-1
4.Cardiac: LV Ejection fraction>40% by Echocardiogram
Pulmonary: SpO2>94 % and FEV1.0%>70%.
Hepatic: total bilirubin>2.0 mg/dl and AST >2.5x ULN.
Renal: Serum creatinine clearance >30 ml/min
Drug allergy used for conditioning or GvHD prophylaxis.
Positive HBs antigen or seropositive to HIV. (Not exclude for seropositive to HCV)
Uncontrolled infection.
Patients inappropriate for transplantation with reasons other than above
51
1st name | |
Middle name | |
Last name | Yoshinobu Kanda |
Saitama Medical Center,Jichi Medical University
Division of Hematology
1-847, Tenuma-cho,Omiya-ku, Saitama
048-647-2111
ycanda-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Kentaro Minagawa |
Kobe University Hospital
Department of General Medicine
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
078-382-6912
kminagaw@med.kobe-u.ac.jp
Saitama Medical Center,Jichi Medical University
None
Self funding
NO
自治医科大学さいたま医療センター 血液内科
山口県立総合医療センター 血液内科
北福島医療センター 血液内科
東北大学医学部 血液内科
松下記念病院 内科
和歌山大学医学部 血液内科
大阪大学医学部 血液・腫瘍内科
大阪市立大学医学部 血液内科
神戸大学医学部 腫瘍・血液内科
府中病院 血液内科
関西医科大学 血液内科
大阪医科大学 血液内科
兵庫医科大学 血液内科
京都府立医科大学 血液内科
2010 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2010 | Year | 07 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2010 | Year | 07 | Month | 23 | Day |
2016 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004725
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