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

NCT02006225 | Unknown Phase 4

• 1 other identifier: TASMC-13-MB-0693-12-CTIL
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autologous Stem Cell Transplantation

Keywords

autologous; stem cell; transplantation

Outcome Measures

Primary Outcomes (1)

• Peripheral blood stem cell content by means of percentage of 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.

  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.

Study Arms (1)

Plerixafor

EXPERIMENTAL

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

Drug: Plerixafor

Interventions

Plerixafor DRUG

Plerixafor

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Healthy stem cells donors
• Patients who older than 30 years
• Patients with non maligancies disease that candidates to autologous stem cell transplantation

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Sanofi: collaborator

MeSH Terms

Interventions

plerixafor

Study Officials

• Menachem Bitan, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menachem Bitan, MD,PhD

CONTACT

972-3-6974270; menachembi@tlvmc.gov.il

Ronit Elhasid, MD

CONTACT

972-3-6974252; ronite@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: February 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: December 10, 2013

Record last verified: 2013-04