Reduced Intensity Stem Cell Transplantation in Children With Relapsed Neuroblastoma After Autologous Transplantation
Allogeneic Hematopoietic Stem Cell Transplantation With Reduced-intensity Conditioning in Children With Neuroblastoma Who Have Failed a Prior Autologous Transplantation
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 19, 2016
November 1, 2015
5.2 years
November 17, 2008
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor response, overall survival, event-free survival
from 1 year after reduced-intensity allogeneic hematopoietic stem cell transplantation
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with NB who have failed a prior auto-SCT will be eligible for the present study. Patients should have no severe comorbid organ dysfunction (NCI grade \> 2 organ toxicity) at enrollment.
You may not qualify if:
- Patients with severe comorbid organ dysfunction (NCI grade \> 2 organ toxicity) prior to RIST will be off the present study.
- Patients with progressed tumor prior to RIST will be off the present study.
- Patients whose parents do not want to undergo RIST will be off the present study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 19, 2008
Study Start
September 1, 2008
Primary Completion
November 1, 2013
Study Completion
November 1, 2015
Last Updated
October 19, 2016
Record last verified: 2015-11