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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02006225

Collaborator

Sanofi (Industry)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autologous Stem Cell Transplantation	Drug: Plerixafor	Phase 4

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:

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.
Morbidity:
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plerixafor The use of plerixafor as additive measurment for the conventional stem cell collection protocol.	Drug: Plerixafor

Arm

Intervention/Treatment

Experimental: Plerixafor

The use of plerixafor as additive measurment for the conventional stem cell collection protocol.

Drug: Plerixafor

Outcome Measures

Primary Outcome Measures

Peripheral blood stem cell content by means of percentage of CD34+ cells [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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center
Sanofi

Investigators

Principal Investigator: Menachem Bitan, MD, Tel-Aviv Sourasky Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT02006225

Other Study ID Numbers:

TASMC-13-MB-0693-12-CTIL

First Posted:

Dec 10, 2013

Last Update Posted:

Dec 10, 2013

Last Verified:

Apr 1, 2013

Keywords provided by Tel-Aviv Sourasky Medical Center

autologous

stem cell

transplantation

Additional relevant MeSH terms:

Plerixafor

Study Results

No Results Posted as of Dec 10, 2013