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

NCT ID: NCT02006225

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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 10mcg/kg GCSF per day and one dose of plerixafor 0.24mg/kg 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.

Conditions

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Autologous Stem Cell Transplantation

Keywords

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autologous stem cell transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plerixafor

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

Group Type EXPERIMENTAL

Plerixafor

Intervention Type DRUG

Interventions

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Plerixafor

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menachem Bitan, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Central Contacts

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Menachem Bitan, MD,PhD

Role: CONTACT

Phone: 972-3-6974270

Email: [email protected]

Ronit Elhasid, MD

Role: CONTACT

Phone: 972-3-6974252

Email: [email protected]

Other Identifiers

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TASMC-13-MB-0693-12-CTIL

Identifier Type: -

Identifier Source: org_study_id