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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02006225
Recruitment Status : Unknown
Verified April 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor

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

Primary Outcome Measures :
  1. 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. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02006225

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Contact: Menachem Bitan, MD,PhD 972-3-6974270
Contact: Ronit Elhasid, MD 972-3-6974252

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Menachem Bitan, MD Tel-Aviv Sourasky Medical Center
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Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT02006225    
Other Study ID Numbers: TASMC-13-MB-0693-12-CTIL
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: April 2013
Keywords provided by Tel-Aviv Sourasky Medical Center:
stem cell
Additional relevant MeSH terms:
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Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents