MedPath

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

Phase 2
Conditions
relapsed/refractory peripheral T-cell non-Hodgkin&#39
s lymphomas
Registration Number
JPRN-UMIN000001485
Lead Sponsor
West Japan Hematology Oncology Group/ Hematological Malignancy Therapy Study Group/ Japan Study Group for Cell Therapy and Transplantation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion 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,

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression free survival at 1 year after transplantation
Secondary Outcome Measures
NameTimeMethod
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
© Copyright 2025. All Rights Reserved by MedPath