Reduced Intensity Stem Cell Transplantation in Children With Relapsed Neuroblastoma After Autologous Transplantation
NCT00793351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2016-10-19
Summary
The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity allogeneic stem cell transplantation (RIST) with RIC regimen in children with neuroblastoma who have failed a prior autologous stem cell transplantation. The investigators will investigate the potential of RIC regimen in inducing antitumor response if the present protocol will indeed reduce the early TRM and allow for sustained donor chimerism.
Conditions
Interventions
- PROCEDURE
-
Reduced-intensity allogeneic hematopoietic stem cell transplantation
Treatment Scheme * Enrollment - Pre-RIST treatment - RIST * 4 cycles of conventional chemotherapy will be given prior to RIST. * Surgery will be done whenever possible prior to RIST. * Local radiotherapy will be applied whenever possible prior to RIST. * topotecan + cyclophosphamide) regimen will be used for pre-RIST conventional chemotherapy. * Cyclophosphamide/Fludarabine (CyFlu) regimen will be used as conditioning regimen for matched related or unrelated SCT. CyFlu-ATG regimen will be used as conditioning regimen for mismatched related SCT.
Sponsors & Collaborators
-
Samsung Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2013-11-30
- Completion
- 2015-11-30
Countries
- South Korea
Study Locations
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