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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT02006225
First received: December 4, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 Intervention Phase
Autologous Stem Cell Transplantation
Drug: Plerixafor
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Peripheral blood stem cell content by means of percentage of CD34+ cells [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plerixafor
The use of plerixafor as additive measurment for the conventional stem cell collection protocol.
Drug: Plerixafor

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:

  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.
  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006225

Contacts
Contact: Menachem Bitan, MD,PhD 972-3-6974270 menachembi@tlvmc.gov.il
Contact: Ronit Elhasid, MD 972-3-6974252 ronite@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Sanofi
Investigators
Principal Investigator: Menachem Bitan, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02006225     History of Changes
Other Study ID Numbers: TASMC-13-MB-0693-12-CTIL
Study First Received: December 4, 2013
Last Updated: December 4, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
autologous
stem cell
transplantation

Additional relevant MeSH terms:
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014