Overview

Stem Cell Harvesting Using GCSF Plus Plerxiafor, in First -Line, for Heavily Pre- Treated Pediatric Oncology Patients.

Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborator:
Sanofi
Treatments:
JM 3100
Plerixafor
Criteria
Inclusion Criteria:

- The following patients will be included in this study:

Patients with high-risk neuroblastoma after third-line chemotherapy. Patients with
high-risk medulloblastoma/PNET after spinal irradiation. Patients with primary sarcomas
after third or more line therapies, Patients with relapsed lymphomas after third line
chemotherapy. Patients with relapsed neuroblastoma, medulloblastoma, lymphoma or sarcoma
after previous autologous stem cell transplantation.

Age equal to or less than 30 years at time of diagnosis. Patients eligible for AHCT
according to their treating protocol or patients with neuroblastoma eligible for
131I-MIBG-therapy.

Patients with maligancies disease who candidates to autologous stem cell transplantation
,taking from them autologus stem cell as back up.

Exclusion Criteria:

Healthy stem cells donors

Patients who older than 30 years

Patients with non maligancies disease that candidates to autologous stem cell
transplantation