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

UMIN ID: UMIN000001485

Registered date:07/11/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
• Date of first enrollment: 2008/11/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Reduced-intensity conditioning followed by allogeneic stem cell transplantation

Outcome(s)

• Primary Outcome: Progression free survival at 1 year after transplantation
• Secondary Outcome: Anti-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 minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Any 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

• Primary Sponsor: West Japan Hematology Oncology Group/ Hematological Malignancy Therapy Study Group/ Japan Study Group for Cell Therapy and Transplantation
• Source(s) of Monetary Support: Hematological Malignancy Therapy Study Group