Stem Cell Harvesting Using GCSF Plus Plerxiafor, in First -Line, for Heavily Pre- Treated Pediatric Oncology Patients.
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Peripheral blood stem cell content by means of percentage of CD34+ cells [ Time Frame: After conditioning protocol (4 days of 10mcg/kg GCSF per day), and on the fifth day after one dose of plerixafor 0.24mg/kg, 10 hours before collection - before harvesting. After harvesting - the number of collected CD34+ cells. ] [ Designated as safety issue: No ]
- Peripheral blood stem cell content before harvesting by means of percentage of CD34+ cells, after conditioning protocol (4 days of 10mcg/kg GCSF per day) and after adding one dose of plerixafor 0.24mg/kg 10 hours before collection.
- Number of CD34+ stem cells that were collected after adding plerixafor with relation to the target number of stem cells needed.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2020|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
The use of plerixafor as additive measurment for the conventional stem cell collection protocol.
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:
- Peripheral blood stem cell content by means of percentage of CD34+ cells, after conditioning protocol (4 days of 10mcg/kg GCSF per day and one dose of plerixafor 0.24mg/kg 10 hours before collection) and before harvesting.
- Number of stem cells harvested.
- Bleeding at the time of catheter placement, during harvesting procedure and post harvesting.
- Infections: localized vs. generalized. Type of pathogen isolated.
- Platelet number and hemoglobin level post harvesting.
- kidney function.
- Duration of hospitalization: Evaluation of the time course from the day of hospitalization for the harvesting to the day of discharge.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02006225
|Contact: Menachem Bitan, MD,PhDfirstname.lastname@example.org|
|Contact: Ronit Elhasid, MDemail@example.com|
|Principal Investigator:||Menachem Bitan, MD||Tel-Aviv Sourasky Medical Center|