UMIN ID: UMIN000003942
Registered date:01/09/2010
Allogeneic HSCT with Fludarabin plus TBI conditioning regimen for elderly patients with hematological malignancies: A phase I/II study
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | 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. |
Date of first enrollment | 2010/08/01 |
Target sample size | 51 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Flu 30mg/m2x4days+Total body irradiaition(TBI)for conditioning. Dose escalation study every 6 doses from 8Gy of TBI. |
Outcome(s)
Primary Outcome | Non-hematological toxicities within 35days after HSCT(Phase I part). One-year disease free survival rate (PhaseII part). |
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Secondary Outcome | Graft failure Regimen related toxicity (RRT) Acute GvHD incidence and severity Relapse Non relapse mortality |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
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Age maximum | 65years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Saitama Medical Center,Jichi Medical University |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Kentaro Minagawa |
Address | 7-5-2, Kusunoki-cho, Chuo-ku, Kobe Japan |
Telephone | 078-382-6912 |
kminagaw@med.kobe-u.ac.jp | |
Affiliation | Kobe University Hospital Department of General Medicine |
scientific contact | |
Name | Yoshinobu Kanda |
Address | 1-847, Tenuma-cho,Omiya-ku, Saitama Japan |
Telephone | 048-647-2111 |
ycanda-tky@umin.ac.jp | |
Affiliation | Saitama Medical Center,Jichi Medical University Division of Hematology |