Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02006225
Status:
UNKNOWN
Last Update Posted:
2013-12-10
First Post:
2013-12-04
Brief Title:
Stem Cell Harvesting Using GCSF Plus Plerxiafor in First -Line for Heavily Pre- Treated Pediatric Oncology Patients
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
GCSF Plus Plerixafor as First-line Treatment for Autologous Stem Cells Harvest in Children With Malignant Diseases in Need for High-dose Chemotherapy With Stem Cell Rescue
Status:
UNKNOWN
Status Verified Date:
2013-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCSF
Brief Summary:
Plerixafor has been intensively used in recent years for harvesting autologous stem cells from lymphoma and myeloma adult patients Its use is indicated after failure to harvest with GCSF alone Nevertheless in the pediatric population its appliance is less well established and the indications are less well confirmed Several disease states and diagnoses may prompt the anticipation of difficulties in harvesting stem cells using GCSF only Such patients may benefit utilizing plerixafor in first-line rather than exhausting the stem cell niche with GCSF alone and only than go for plerixafor as second-line rescue procedure
In this study we propose to examine the applicability and feasibility of harvesting autologous stem cells by means of GCSF plerixafor in first-line measure for pediatric patients with specific indications
In this study we propose to examine the applicability and feasibility of harvesting autologous stem cells by means of GCSF plerixafor in first-line measure for pediatric patients with specific indications
Detailed Description:
Improve and report outcomes of children undergoing peripheral stem and progenitor cell harvesting applying plerixafor in first-line aphaeresis including
Pre-harvesting FACS-derived CD34 cell number Number of stem cells harvested Number of T-cells harvested Days of hospitalization
Procedure related toxicity including
Infections Line complications Other organ toxicities
Compare outcomes of plerixafor-derived stem and progenitor cells harvesting between different pediatric oncological diseases including high-risk neuroblastoma high-risk brain tumors high-risk sarcomas and relapsed lymphomas
Outcomes to be analyzed
1 Peripheral blood stem cell content by means of percentage of CD34 cells after conditioning protocol 4 days of 10mcgkg GCSF per day and one dose of plerixafor 024mgkg 10 hours before collection and before harvesting
2 Number of stem cells harvested
3 Morbidity
1 Bleeding at the time of catheter placement during harvesting procedure and post harvesting
2 Infections localized vs generalized Type of pathogen isolated
4 Platelet number and hemoglobin level post harvesting
5 kidney function
6 Duration of hospitalization Evaluation of the time course from the day of hospitalization for the harvesting to the day of discharge
Pre-harvesting FACS-derived CD34 cell number Number of stem cells harvested Number of T-cells harvested Days of hospitalization
Procedure related toxicity including
Infections Line complications Other organ toxicities
Compare outcomes of plerixafor-derived stem and progenitor cells harvesting between different pediatric oncological diseases including high-risk neuroblastoma high-risk brain tumors high-risk sarcomas and relapsed lymphomas
Outcomes to be analyzed
1 Peripheral blood stem cell content by means of percentage of CD34 cells after conditioning protocol 4 days of 10mcgkg GCSF per day and one dose of plerixafor 024mgkg 10 hours before collection and before harvesting
2 Number of stem cells harvested
3 Morbidity
1 Bleeding at the time of catheter placement during harvesting procedure and post harvesting
2 Infections localized vs generalized Type of pathogen isolated
4 Platelet number and hemoglobin level post harvesting
5 kidney function
6 Duration of hospitalization Evaluation of the time course from the day of hospitalization for the harvesting to the day of discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None