NeuroblastomaPhase 2NCT01807468
Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
A Phase 2 study testing haploidentical stem cell transplantation and NK cell therapy in people with Neuroblastoma and Ewing Sarcoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma
- What is being tested?
- haploidentical stem cell transplantation and NK cell therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Jun 2019
- Phase
- Phase 2
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age < 21 years old
- Patients with high-risk solid tumors who failed prior HDCT/autoSCT
- Patients with a suitable haploidentical donor
- High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
- stable disease with salvage chemotherapy after relapse
Who cannot join
- organ dysfunction(NCI common toxicity criteria grade > 2)
- progression of disease despite salvage chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation
To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
Read the detailed description
HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.
- Being tested
- haploidentical stem cell transplantation and NK cell therapy
- Keywords
- haploidentical stem cell transplantation, natural killer cell therapy, pediatric solid tumor
- Medical subject headings
- Neuroblastoma, Sarcoma, Ewing, Rhabdomyosarcoma, Osteosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
haploidentical stem cell transplantation and NK cell therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HaploSC+NK | Experimental | Not described Receives: Procedure: haploidentical stem cell transplantation and NK cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
Measured: within 30 days after transplantation
Secondary outcomes (1)
event-free survival and overall survival
efficacy of haploidentical stem cell transplantation and NK cell infusion in patients with high-risk solid tumors
Measured: 3 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Samsung 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KiWoong Sung, Samsung Medical Center
- Investigators
- Ki Woong Sung, MD, PhD, Principal investigator, Department of Pediatrics, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807468
- Sponsor's protocol ID
- CR0113061
- Status last verified
- Sep 2018
- First submitted
- 26 Feb 2013
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01807468
- Acronym / sponsor ID
- CR0113061
- Keywords
- haploidentical stem cell transplantation, natural killer cell therapy, pediatric solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Mar 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.
To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.
Detailed description
HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HaploSC+NK | Experimental | Procedure: haploidentical stem cell transplantation and NK cell therapy |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age < 21 years old
- Patients with high-risk solid tumors who failed prior HDCT/autoSCT
- Patients with a suitable haploidentical donor
- High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
- stable disease with salvage chemotherapy after relapse
Key exclusion criteria (2 listed)
- organ dysfunction(NCI common toxicity criteria grade > 2)
- progression of disease despite salvage chemotherapy
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 |
|---|---|---|
| haploidentical stem cell transplantation and NK cell therapy | Procedure or surgery | HaploSC+NK |
Primary outcome
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
Time frame: within 30 days after transplantation
1 secondary outcome
event-free survival and overall survival
Time frame: 3 years after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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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.
Ki Woong Sung, MD, PhD principal investigator
Department of Pediatrics, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing haploidentical stem cell transplantation and NK cell therapy in people with Neuroblastoma and Ewing Sarcoma, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 2 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion (time frame: within 30 days after transplantation). 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 18 Sep 2018.