Clinical trial · Interventional
Stem Cell Harvesting Using GCSF Plus Plerxiafor, in First -Line, for Heavily Pre- Treated Pediatric Oncology Patients.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Plerixafor
- description
- The use of plerixafor as additive measurment for the conventional stem cell collection protocol.
- interventionNames
- Drug: Plerixafor
Primary outcomes (1)
- measure
- Peripheral blood stem cell content by means of percentage of CD34+ cells
- timeFrame
- 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.
- description
- 1. 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. 2. Number of CD34+ stem cells that were collected after adding plerixafor with relation to the target number of stem cells needed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available