A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- progression free survival
Study Overview
Brief Summary
To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation
Detailed Description
Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
- •ECOG: 0-2
- •Tbil < 1.5x ULN and AST/ALT <2.5x ULN
- •With informed consent
Exclusion Criteria
- •Life expectancy < 3 months
- •Women in pregnancy
- •uncontrollable infection disease
- •serum Cr >400mmol/l
- •uncontroled diabetis and heart disease
Arms & Interventions
Consolidation chemo
Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen
Intervention: Bu-CY-E (Drug)
Outcomes
Primary Outcomes
progression free survival
Time Frame: 2-year
Secondary Outcomes
- overall survival(2-year)
- progression(2-year)
- transplantation-related mortality(2-year)
Investigators
Jiong HU
Head, Blood & Marrow Transplantation Center
Shanghai Jiao Tong University School of Medicine