NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studied1. 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 enrollment2010/08/01
Target sample size51
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Flu 30mg/m2x4days+Total body irradiaition(TBI)for conditioning. Dose escalation study every 6 doses from 8Gy of TBI.

Outcome(s)

Primary OutcomeNon-hematological toxicities within 35days after HSCT(Phase I part). One-year disease free survival rate (PhaseII part).
Secondary OutcomeGraft failure Regimen related toxicity (RRT) Acute GvHD incidence and severity Relapse Non relapse mortality

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteriaDrug 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

Contact

public contact
Name Kentaro Minagawa
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe Japan
Telephone 078-382-6912
E-mail 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
E-mail ycanda-tky@umin.ac.jp
Affiliation Saitama Medical Center,Jichi Medical University Division of Hematology