NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001485

Registered date:07/11/2008

Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedrelapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Date of first enrollment2008/11/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Reduced-intensity conditioning followed by allogeneic stem cell transplantation

Outcome(s)

Primary OutcomeProgression free survival at 1 year after transplantation
Secondary OutcomeAnti-lymphoma effect at day 100 after transplantation, treatment-related toxicity and mortality at day 100 after transplantation, engraftment at day 60 after transplantation, time to hematopoietic recovery, incidence and severity of acute GVHD

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximum65years-old
GenderMale and Female
Include criteriaPTCL (ALK negative anaplastic large cell lymphoma, Angioimmunoblastic T-cell lymphoma, Peripheral T-cell lymphoma, not other specified) Patients with diseases described as follows. SD/PD after first-line chemotherapy or 1st/2nd relapsed patients whose disease is controlled by salvage chemotherapy to CR or PR. PR/SD after second-line chemotherapy in patients whose response after first-line chemotherapy were PR. Any of the following is required. 1) Between 16 and 65 years old 2) Performance status(ECOG) 0-2 3) First allogeneic stem cell transplantation 4) Any of the following donors is available.1. Serologically HLA- matched or -one antigen mismatched-related donor 2. HLA-matched or one allele of HLA-DRB1mismatched-unrelated donor 3. Cord blood unit serologically matched at least 4 of 6 HLA antigens(A,B,DR) and with cryopreserved total nucleated cell dose of more than 2x10E7/kg 5) Written informed consent to participate the trial
Exclude criteriaAny of the following. A history of autologous transplantation just before enrolment, Positive for HLA antibody (in case of cord blood transplantation), SaO2 bellow 94% in room air, T.Bil over 2.0 mg/dL, Serum creatinine over 2.0 mg/dL, AST or ALT over 2.5xULN, Uncontrolled diabetes, Uncontrolled hypertension, History of severe cardiac disease, Left ventricular ejection fraction smaller than 50%, Patients with other malignant comorbidity, Uncontrolled active infection, Positive for TPHA or HTLV-1 antibody or HIV antibody or HBs antigen, Uncontrolled psychiatric disease, Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, Pregnant or during breast feeding, Cases that physicians judged as inappropriate,

Related Information

Contact

public contact
Name Yoshinobu Maeda, M.D., Ph.D
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Telephone 086-235-7227
E-mail yosmaeda@md.okayama-u.ac.jp
Affiliation Okayama University Hospital Department of Hematology and Oncology
scientific contact
Name Yoshinobu Maeda
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Telephone 086-235-7227
E-mail yosmaeda@md.okayama-u.ac.jp
Affiliation Okayama University Hospital Department of Hematology and Oncology