NeuroblastomaPhase 1NCT02130869
A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas
A Phase 1 study testing CD133+ selected autologous stem cell infusion, IL-2 and hu14.18K322A in people with Neuroblastoma and Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Neuroblastoma, Lymphoma, High-risk Tumor
- What is being tested?
- CD133+ selected autologous stem cell infusion, IL-2 and hu14.18K322A
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2014to 20 Dec 2017
- Phase
- Phase 1
- 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
- At least 18 years of age.
- Partially HLA matched family member.
- Human immunodeficiency virus (HIV) negative.
- (Female only) Is not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- (Female only) Is not breastfeeding.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a haploidentical family member will be given after high dose chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma, the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic cell recovery will be evaluated and survival of children treated with this approach will be determined.
The investigators expect to enroll 36 participants. Haploidentical family members (donors) will also be recruited to provide natural killer cells.
Read the detailed description
Primary Objective:
- To evaluate day +35 ANC engraftment in autologous stem cell transplantation for high risk pediatric malignancies after stem cell selection and immunotherapy.
Secondary Objectives
- To estimate incidence of relapse, disease-free survival and overall survival.
- To characterize lymphocyte and hematopoietic reconstitution in these patients.
- To describe the characteristics of the stem cell and natural killer cell grafts.
- To estimate the overall survival of patients treated without stem cell manipulation or NK cell infusion due to off therapy criteria
- Conditions
- Neuroblastoma, Lymphoma, High-risk Tumor
- Keywords
- Autologous stem cell transplantation, Natural killer cells
- Medical subject headings
- Neuroblastoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD133+ selected autologous stem cell infusionBiological
Also called Natural killer (NK) cell infusion
Hematopoietic stem cells will be collected from children with high-risk solid tumors. After collection, they will be immuno-magnetically selected using CD133 as a marker in efforts to reduce tumor cell contamination in the stem cell graft. After high dose chemotherapy, those selected stem cells will be infused, followed shortly thereafter by an infusion of haploidentical natural killer cells.
IL-2Biological
Also called Interleukin-2, Aldesleukin, Proleukin(R)
Following infusion of haploidentical natural killer cells, interleukin-2 (IL-2) subcutaneously (SQ) will be given to support the in vivo survival of donor NK cells.
hu14.18K322ABiological
Also called anti-GD2 antibody, Hu14.18K322MAB
Participants with neuroblastoma (Group A) will receive hu14.18K322A intravenously (IV).
BusulfanDrug
Also called Busulfex(R), Myleran(R)
Given IV - Group A only.
MelphalanDrug
Also called L-phenylalanine mustard, Phenylalanine mustard, L-PAM, L-sarcolysin
Given IV - All groups.
GM-CSFBiological
Also called Sargramostim, Leukine(R)
Given SQ - All groups.
BendamustineDrug
Also called Treanda®, Bendamustine hydrochloride
Given IV - Group B only.
EtoposideDrug
Also called VP-16, Vepesid(R)
Given IV - Group B and Group C. In case of etoposide reactions, etoposide phosphate will be given.
CytarabineDrug
Also called ARA-C
Given IV - Group B only.
CarboplatinDrug
Also called Inorganic heavy metal coordination complex
Given IV - Group C only.
Haploidentical natural killer cell infusionDevice
Also called NK cell infusion
NK cell product will be collected from donors using leukapheresis procedures. The autologous hematopoietic stem cell graft product will be positively selected using the investigational CliniMACS device and CD133 Microbead reagent. Following standard laboratory procedures, the NK cell product will be enumerated and assessed for viable cell content. NK cells will be infused by slow IV push over 3 to 15 minutes immediately after processing, evaluation and release testing.
G-CSFBiological
Also called Filgrastim, Neupogen(R)
Given SQ - All Groups.
Etoposide phosphateDrug
Also called Etopophos(R)
In case of etoposide reactions, etoposide phosphate will be given IV. - Group B and Group C only.
CliniMACSDevice
Also called Cell Selection System
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Neuroblastoma | Experimental | All participants first receive standard of care high-dose chemotherapy specific to their tumor type. Group A participants receive busulfan, melphalan, CD133+ selected autologous stem cell infusion, hu14.18K322A, IL-2, haploidentical natural killer cell infusion, G-CSF, and GM-CSF.
Cells for infusion are prepared using the CliniMACS System. Receives: Biological: CD133+ selected autologous stem cell infusion; Biological: IL-2; Biological: hu14.18K322A; Drug: Busulfan; Drug: Melphalan; Biological: GM-CSF; Device: Haploidentical natural killer cell infusion; Biological: G-CSF; Device: CliniMACS |
| Group B: Lymphoma | Experimental | All participants first receive standard of care high-dose chemotherapy specific to their tumor type. Group B participants receive bendamustine, etoposide (or etoposide phosphate), cytarabine, melphalan, CD133+ selected autologous stem cell infusion, IL-2, haploidentical natural killer cell infusion, G-CSF, and GM-CSF.
Cells for infusion are prepared using the CliniMACS System. Receives: Biological: CD133+ selected autologous stem cell infusion; Biological: IL-2; Drug: Melphalan; Biological: GM-CSF; Drug: Bendamustine; Drug: Etoposide; Drug: Cytarabine; Device: Haploidentical natural killer cell infusion; Biological: G-CSF; Drug: Etoposide phosphate; Device: CliniMACS |
| Group C: High-Risk Tumors | Experimental | All participants first receive standard of care high-dose chemotherapy specific to their tumor type. Group C participants receive melphalan, etoposide (or etoposide phosphate), carboplatin, CD133+ selected autologous stem cell infusion, IL-2, haploidentical natural killer cell infusion, G-CSF, and GM-CSF.
Cells for infusion are prepared using the CliniMACS System. Receives: Biological: CD133+ selected autologous stem cell infusion; Biological: IL-2; Drug: Melphalan; Biological: GM-CSF; Drug: Etoposide; Drug: Carboplatin; Device: Haploidentical natural killer cell infusion; Biological: G-CSF; Drug: Etoposide phosphate; Device: CliniMACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants with positive ANC engraftment
Feasibility will be determined based on ANC engraftment defined as ANC ≥500/mm^3 for 3 consecutive tests performed on different days evaluated before day 35 post-transplant. If the study is considered feasible, the ANC engraftment rate will be 100% (95% Blyth-Still-Casella (BSC) CI: 76.45%-100%) without any failure, 92% (BSC 95% CI: 65.11%-99.57%) with 1 failure, and 83% (BSC 95% CI: 55%-96.95%) with 2 failures. In addition, if more than 2 (≥ 3) on-therapy patients die due to any protocol treatment-related causes during the first 12 months post-transplant across all groups (3 deaths among 36 participants), the study will be stopped. Deaths due to treatment not specified in this protocol will not be included in evaluation of this stopping rule.
Measured: Day 35 post transplant
Secondary outcomes (7)
Overall survival
Overall survival is defined based on any death. The Kaplan-Meier Estimate will be provided.
Measured: Up to one year after transplantation
Disease-free survival
Disease-free survival is defined based on any death, graft failure, or relapsed/resistant disease. The Kaplan-Meier Estimate will be provided.
Measured: Up to one year after transplantation
Incidence of relapse
Cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event.
Measured: Up to one year after transplantation
Lymphocyte and hematopoietic reconstitution
The hematopoietic cell recovery and engraftment rates will be reported with a Blyth-Still-Casella 95% confidence interval.
Measured: Up to one year after transplantation
Characteristics of the stem cell grafts
Results will be reported and presented descriptively.
Measured: Up to one year after transplantation
Characteristics of the natural killer cell grafts.
Results will be reported and presented descriptively.
Measured: Up to one year after transplantation
Overall survival of patients treated without stem cell manipulation or NK cell infusion due to off therapy criteria
The Kaplan-Meier estimate will be provided for overall survival analysis.
Measured: Up to one year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start10 Oct 2014
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
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 St. Jude Children's Research HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brandon M. Triplett, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130869
- Sponsor's protocol ID
- ASCIST
- Other IDs
- NCI-2014-00275
- Status last verified
- Dec 2017
- First submitted
- 1 May 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas
- ClinicalTrials.gov ID
- NCT02130869
- Acronym / sponsor ID
- ASCIST
- Conditions
- Neuroblastoma, Lymphoma, High-risk Tumor
- Keywords
- Autologous stem cell transplantation, Natural killer cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 10 Oct 2014 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 6 May 2014 (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.
This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a haploidentical family member will be given after high dose chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma, the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic cell recovery will be evaluated and survival of children treated with this approach will be determined.
The investigators expect to enroll 36 participants. Haploidentical family members (donors) will also be recruited to provide natural killer cells.
Detailed description
Primary Objective:
- To evaluate day +35 ANC engraftment in autologous stem cell transplantation for high risk pediatric malignancies after stem cell selection and immunotherapy.
Secondary Objectives
- To estimate incidence of relapse, disease-free survival and overall survival.
- To characterize lymphocyte and hematopoietic reconstitution in these patients.
- To describe the characteristics of the stem cell and natural killer cell grafts.
- To estimate the overall survival of patients treated without stem cell manipulation or NK cell infusion due to off therapy criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Neuroblastoma | Experimental | Biological: CD133+ selected autologous stem cell infusion, Biological: IL-2, Biological: hu14.18K322A, Drug: Busulfan, Drug: Melphalan, Biological: GM-CSF, Device: Haploidentical natural killer cell infusion, Biological: G-CSF, Device: CliniMACSAll participants first receive standard of care high-dose chemotherapy specific to their tumor type. Group A participants receive busulfan, melphalan, CD133+ selected autologous stem cell infusion, hu14.18K322A, IL-2, haploidentical natural killer cell infusion, G-CSF, and GM-CSF. Cells for infusion are prepared using the CliniMACS System. |
| Group B: Lymphoma | Experimental | Biological: CD133+ selected autologous stem cell infusion, Biological: IL-2, Drug: Melphalan, Biological: GM-CSF, Drug: Bendamustine, Drug: Etoposide, Drug: Cytarabine, Device: Haploidentical natural killer cell infusion, Biological: G-CSF, Drug: Etoposide phosphate, Device: CliniMACSAll participants first receive standard of care high-dose chemotherapy specific to their tumor type. Group B participants receive bendamustine, etoposide (or etoposide phosphate), cytarabine, melphalan, CD133+ selected autologous stem cell infusion, IL-2, haploidentical natural killer cell infusion, G-CSF, and GM-CSF. Cells for infusion are prepared using the CliniMACS System. |
| Group C: High-Risk Tumors | Experimental | Biological: CD133+ selected autologous stem cell infusion, Biological: IL-2, Drug: Melphalan, Biological: GM-CSF, Drug: Etoposide, Drug: Carboplatin, Device: Haploidentical natural killer cell infusion, Biological: G-CSF, Drug: Etoposide phosphate, Device: CliniMACSAll participants first receive standard of care high-dose chemotherapy specific to their tumor type. Group C participants receive melphalan, etoposide (or etoposide phosphate), carboplatin, CD133+ selected autologous stem cell infusion, IL-2, haploidentical natural killer cell infusion, G-CSF, and GM-CSF. Cells for infusion are prepared using the CliniMACS System. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- At least 18 years of age.
- Partially HLA matched family member.
- Human immunodeficiency virus (HIV) negative.
- (Female only) Is not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- (Female only) Is not breastfeeding.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CD133+ selected autologous stem cell infusionAlso: Natural killer (NK) cell infusionHematopoietic stem cells will be collected from children with high-risk solid tumors. After collection, they will be immuno-magnetically selected using CD133 as a marker in efforts to reduce tumor cell contamination in the stem cell graft. After high dose chemotherapy, those selected stem cells will be infused, followed shortly thereafter by an infusion of haploidentical natural killer cells. | Biological | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
| IL-2Also: Interleukin-2, Aldesleukin, Proleukin(R)Following infusion of haploidentical natural killer cells, interleukin-2 (IL-2) subcutaneously (SQ) will be given to support the in vivo survival of donor NK cells. | Biological | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
| hu14.18K322AAlso: anti-GD2 antibody, Hu14.18K322MABParticipants with neuroblastoma (Group A) will receive hu14.18K322A intravenously (IV). | Biological | Group A: Neuroblastoma |
| BusulfanAlso: Busulfex(R), Myleran(R)Given IV - Group A only. | Drug | Group A: Neuroblastoma |
| MelphalanAlso: L-phenylalanine mustard, Phenylalanine mustard, L-PAM, L-sarcolysinGiven IV - All groups. | Drug | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
| GM-CSFAlso: Sargramostim, Leukine(R)Given SQ - All groups. | Biological | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
| BendamustineAlso: Treanda®, Bendamustine hydrochlorideGiven IV - Group B only. | Drug | Group B: Lymphoma |
| EtoposideAlso: VP-16, Vepesid(R)Given IV - Group B and Group C. In case of etoposide reactions, etoposide phosphate will be given. | Drug | Group B: Lymphoma, Group C: High-Risk Tumors |
| CytarabineAlso: ARA-CGiven IV - Group B only. | Drug | Group B: Lymphoma |
| CarboplatinAlso: Inorganic heavy metal coordination complexGiven IV - Group C only. | Drug | Group C: High-Risk Tumors |
| Haploidentical natural killer cell infusionAlso: NK cell infusionNK cell product will be collected from donors using leukapheresis procedures. The autologous hematopoietic stem cell graft product will be positively selected using the investigational CliniMACS device and CD133 Microbead reagent. Following standard laboratory procedures, the NK cell product will be enumerated and assessed for viable cell content. NK cells will be infused by slow IV push over 3 to 15 minutes immediately after processing, evaluation and release testing. | Device | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
| G-CSFAlso: Filgrastim, Neupogen(R)Given SQ - All Groups. | Biological | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
| Etoposide phosphateAlso: Etopophos(R)In case of etoposide reactions, etoposide phosphate will be given IV. - Group B and Group C only. | Drug | Group B: Lymphoma, Group C: High-Risk Tumors |
| CliniMACSAlso: Cell Selection SystemThe mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells. | Device | Group A: Neuroblastoma, Group B: Lymphoma, Group C: High-Risk Tumors |
Primary outcome
Percent of participants with positive ANC engraftment
Time frame: Day 35 post transplant
Feasibility will be determined based on ANC engraftment defined as ANC ≥500/mm^3 for 3 consecutive tests performed on different days evaluated before day 35 post-transplant. If the study is considered feasible, the ANC engraftment rate will be 100% (95% Blyth-Still-Casella (BSC) CI: 76.45%-100%) without any failure, 92% (BSC 95% CI: 65.11%-99.57%) with 1 failure, and 83% (BSC 95% CI: 55%-96.95%) with 2 failures. In addition, if more than 2 (≥ 3) on-therapy patients die due to any protocol treatment-related causes during the first 12 months post-transplant across all groups (3 deaths among 36 participants), the study will be stopped. Deaths due to treatment not specified in this protocol will not be included in evaluation of this stopping rule.
7 secondary outcomes
Overall survival
Time frame: Up to one year after transplantation
Disease-free survival
Time frame: Up to one year after transplantation
Incidence of relapse
Time frame: Up to one year after transplantation
Lymphocyte and hematopoietic reconstitution
Time frame: Up to one year after transplantation
Characteristics of the stem cell grafts
Time frame: Up to one year after transplantation
Characteristics of the natural killer cell grafts.
Time frame: Up to one year after transplantation
Overall survival of patients treated without stem cell manipulation or NK cell infusion due to off therapy criteria
Time frame: Up to one year after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Brandon M. Triplett, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD133+ selected autologous stem cell infusion, IL-2 and hu14.18K322A in people with Neuroblastoma and Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 22 Dec 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of participants with positive ANC engraftment (time frame: Day 35 post transplant). 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 22 Dec 2017.