Autologous Stem Cell TransplantationPhase 4GCSFNCT02006225
Stem Cell Harvesting Using GCSF Plus Plerxiafor, in First -Line, for Heavily Pre- Treated Pediatric Oncology Patients.
A Phase 4 study testing Plerixafor in people with Autologous Stem Cell Transplantation, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Autologous Stem Cell Transplantation
- What is being tested?
- Plerixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Healthy stem cells donors
- Patients who older than 30 years
- Patients with non maligancies disease that candidates to autologous stem cell transplantation
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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:
- Bleeding at the time of catheter placement, during harvesting procedure and post harvesting.
- 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.
- Conditions
- Autologous Stem Cell Transplantation
- Being tested
- Plerixafor
- Keywords
- autologous, stem cell, transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor | Experimental | The use of plerixafor as additive measurment for the conventional stem cell collection protocol. Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Menachem Bitan, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006225
- Sponsor's protocol ID
- TASMC-13-MB-0693-12-CTIL
- Acronym
- GCSF
- Status last verified
- Apr 2013
- First submitted
- 4 Dec 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02006225
- Acronym / sponsor ID
- GCSF / TASMC-13-MB-0693-12-CTIL
- Conditions
- Autologous Stem Cell Transplantation
- Keywords
- autologous, stem cell, transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Sanofi
- Study start
- Feb 2014
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Bleeding at the time of catheter placement, during harvesting procedure and post harvesting.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plerixafor | Experimental | Drug: PlerixaforThe use of plerixafor as additive measurment for the conventional stem cell collection protocol. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Healthy stem cells donors
- Patients who older than 30 years
- Patients with non maligancies disease that candidates to autologous stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plerixafor | Drug | Plerixafor |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Bitan, MD principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plerixafor in people with Autologous Stem Cell Transplantation, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menachem Bitan, MD,PhD (972-3-6974270, menachembi@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.