Stem Cell Harvesting Using GCSF Plus Plerxiafor, in First... | NCT02006225

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

NCT02006225

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 10, 2013Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Autologous Stem Cell Transplantation

Interventions

Plerixafor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Feb 2019Estimated

Completion Date

Feb 2020Estimated

First Submitted Date

Dec 4, 2013

First Submission Date that Met QC Criteria

Dec 4, 2013

First Posted Date

Dec 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2013

Last Update Posted Date

Dec 10, 2013Estimated

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:
1. Bleeding at the time of catheter placement, during harvesting procedure and post harvesting.
2. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Plerixafor	Experimental	The use of plerixafor as additive measurment for the conventional stem cell collection protocol.	Drug: Plerixafor

Name	Type	Description	Arm Group Labels	Other Names
Plerixafor	Drug		Plerixafor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peripheral blood stem cell content by means of percentage of 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.	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Menachem Bitan, MD,PhD	Contact	972-3-6974270		menachembi@tlvmc.gov.il
Ronit Elhasid, MD	Contact	972-3-6974252		ronite@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Menachem Bitan, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Not provided