Ewing SarcomaPhase 1NCT01625351
A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
A Phase 1 study testing alemtuzumab, fludarabine and sirolimus in people with Ewing Sarcoma and Gastrointestinal Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Ewing Sarcoma, Gastrointestinal Tumor, Germ Cell Tumor
- What is being tested?
- alemtuzumab, fludarabine and sirolimus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2012to 10 Feb 2020
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- At least 2 years of age and less than or equal to 21 years of age.
- Histologically confirmed solid tumor or lymphoma at original diagnosis:
- Ewing Sarcoma Family of Tumors (ESFT)
- Gastrointestinal tumors
- Germ Cell tumors
- Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma)
Show all 24Show fewer
- Lymphoma (including Hodgkin and non-Hodgkin lymphoma)
- Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and renal cell carcinoma)
- Melanoma
- Neuroblastoma
- Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma)
- Malignancy has no reasonable expectation of cure with available alternative salvage therapy.
- Has a suitable human leukocyte antigen (HLA) haploidentical donor available.
- At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy.
- Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the PI.
- Shortening fraction greater than or equal to 25%.
- Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50 mL/min/1.73 m2.
- Pulse oximetry greater than or equal to 92% on room air
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3 times the upper limit of the institution-established normal range.
- Direct bilirubin less than or equal to 3.0 mg/dL.
- Karnofsky or Lansky performance score of greater than or equal to 50.
- At least 18 years of age.
- Partially HLA matched family member.
- Human immunodeficiency virus (HIV) negative.
Who cannot join
- Newly diagnosed patients with no prior attempt at curative therapy.
- Any primary or active central nervous system (CNS) malignancy, including metastatic disease.
- Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy.
- Prior allogeneic hematopoietic stem cell transplant.
- Prior autologous stem cell transplant within previous 3 months.
- Allergy to murine products or positive human anti-mouse antibody (HAMA).
Show all 10Show fewer
- (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- (Female only) Breast feeding.
- (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- (Female only) Breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.
Read the detailed description
Twelve participants and 12 donors will be enrolled on this study. Donors will undergo seven days of hematopoietic stem cell (HSC) mobilization followed by two apheresis collections. Each apheresis collection will be processed by the CliniMACS system.
DONORS: A mobilization regimen of granulocyte colony stimulating factor (G-CSF) will be used to obtain a peripheral blood stem cell (PBSC) product from the donor. Apheresis will be performed for a minimum of two consecutive days, including one day for each cell product delivered.
STUDY PARTICIPANTS: Participants will undergo a two-stage haploidentical cell infusion following myeloablative conditioning. The first cell infusion will be a CD3-depleted product and the second infusion will be a CD45RA-depleted product.
Primary Objective:
- To determine the feasibility of haploidentical HSCT using two infusions engineered by negative selection on the Miltenyi CliniMACS system- the first by selective depletion of CD3+ cells, followed by a second depleted of CD45RA+ cells, in children with relapsed or refractory solid tumors or lymphomas.
Secondary Objectives:
- To estimate hematopoietic cell recovery and engraftment rates for the patients.
- To estimate infection rates and complications.
- To estimate the one-year overall survival (OS) and event-free survival (EFS) for the study patients.
- Conditions
- Ewing Sarcoma, Gastrointestinal Tumor, Germ Cell Tumor, Hepatic Tumor, Lymphoma, Wilms Tumor
- Being tested
- alemtuzumab, fludarabine, sirolimus, Busulfan, melphalan
- Medical subject headings
- Sarcoma, Ewing, Digestive System Neoplasms, Neoplasms, Germ Cell and Embryonal, Carcinoma, Hepatocellular, Lymphoma, Wilms Tumor, Rhabdoid Tumor, Adenocarcinoma, Clear Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabDrug
Also called CAMPATH-1H, Campath(R)
Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation).
fludarabineDrug
Also called Fludara(R)
Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.)
sirolimusDrug
Also called Rapamycin, Rapamune(R)
Patients receive sirolimus beginning on day -1 with taper beginning on day 90. (Day 0 = stem cell transplantation.)
Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy.
BusulfanDrug
Also called Busulfex(R), Myleran(R)
Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.)
melphalanDrug
Also called L-phenylalanine mustard, phenylalanine mustard, L-PAM, L-sarcolysin
Patients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.)
stem cellsBiological
Also called HSCT, Stem cell transplantation
Patients undergo CD3 depleted haploidentical hematopoietic stem cell transplant (HSCT) on day 0. Patients also undergo CD45RA depleted HSCT infusion on day 1. (Day 0 = stem cell transplantation.)
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 |
|---|---|---|
| Treatment | Experimental | Participants to undergo transplantation. They receive alemtuzumab, fludarabine, sirolimus, busulfan, melphalan, and stem cells.
Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy.
Cells for infusion are prepared using the CliniMACS System. Receives: Drug: alemtuzumab; Drug: fludarabine; Drug: sirolimus; Drug: Busulfan; Drug: melphalan; Biological: stem cells; Device: CliniMACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of haploidentical HSCT
Feasibility is defined as engraftment (ANC≥ 500/mm3 for 3 consecutive tests performed on different days) evaluated before day +30.
Measured: 30 days post transplantation
Secondary outcomes (4)
hematopoietic cell recovery and engraftment rates
They will be reported and presented descriptively. Specifically, the hematopoietic cell recovery and engraftment rates will be reported with a Blyth-Still-Casella 95% confidence interval.
Measured: 30 days post transplantation
infection rates and complications
The proportion of patients who develop infections and complications will be estimated and a Blyth-Still-Casella 95% confidence interval will be provided.
Measured: up to 5 years
overall survival (OS)
Defined based on any death. The Kaplan-Meier Estimate will be provided.
Measured: up to 1 year after transplantation
event-free survival
The Kaplan-Meier Estimate will be provided.
Measured: up to 1 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 posted21 Jun 2012 (estimated)
- Study start20 Aug 2012
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CURE Childhood Cancer, Inc.
- Responsible party
- Sponsor
- Investigators
- Brando Triplett, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625351
- Sponsor's protocol ID
- RADIANT
- Other IDs
- NCI-2012-00588
- Status last verified
- Feb 2026
- First submitted
- 19 Jun 2012
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT01625351
- Acronym / sponsor ID
- RADIANT
- Conditions
- Ewing Sarcoma, Gastrointestinal Tumor, Germ Cell Tumor, Hepatic Tumor, Lymphoma, Wilms Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- CURE Childhood Cancer, Inc.
- Study start
- 20 Aug 2012 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 21 Jun 2012 (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 phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.
Detailed description
Twelve participants and 12 donors will be enrolled on this study. Donors will undergo seven days of hematopoietic stem cell (HSC) mobilization followed by two apheresis collections. Each apheresis collection will be processed by the CliniMACS system.
DONORS: A mobilization regimen of granulocyte colony stimulating factor (G-CSF) will be used to obtain a peripheral blood stem cell (PBSC) product from the donor. Apheresis will be performed for a minimum of two consecutive days, including one day for each cell product delivered.
STUDY PARTICIPANTS: Participants will undergo a two-stage haploidentical cell infusion following myeloablative conditioning. The first cell infusion will be a CD3-depleted product and the second infusion will be a CD45RA-depleted product.
Primary Objective:
- To determine the feasibility of haploidentical HSCT using two infusions engineered by negative selection on the Miltenyi CliniMACS system- the first by selective depletion of CD3+ cells, followed by a second depleted of CD45RA+ cells, in children with relapsed or refractory solid tumors or lymphomas.
Secondary Objectives:
- To estimate hematopoietic cell recovery and engraftment rates for the patients.
- To estimate infection rates and complications.
- To estimate the one-year overall survival (OS) and event-free survival (EFS) for the study patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: alemtuzumab, Drug: fludarabine, Drug: sirolimus, Drug: Busulfan, Drug: melphalan, Biological: stem cells, Device: CliniMACSParticipants to undergo transplantation. They receive alemtuzumab, fludarabine, sirolimus, busulfan, melphalan, and stem cells. Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy. Cells for infusion are prepared using the CliniMACS System. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- At least 2 years of age and less than or equal to 21 years of age.
- Histologically confirmed solid tumor or lymphoma at original diagnosis:
- Malignancy has no reasonable expectation of cure with available alternative salvage therapy.
- Has a suitable human leukocyte antigen (HLA) haploidentical donor available.
- At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy.
Key exclusion criteria (10 listed)
- Newly diagnosed patients with no prior attempt at curative therapy.
- Any primary or active central nervous system (CNS) malignancy, including metastatic disease.
- Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy.
- Prior allogeneic hematopoietic stem cell transplant.
- Prior autologous stem cell transplant within previous 3 months.
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 |
|---|---|---|
| alemtuzumabAlso: CAMPATH-1H, Campath(R)Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation). | Drug | Treatment |
| fludarabineAlso: Fludara(R)Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.) | Drug | Treatment |
| sirolimusAlso: Rapamycin, Rapamune(R)Patients receive sirolimus beginning on day -1 with taper beginning on day 90. (Day 0 = stem cell transplantation.) Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy. | Drug | Treatment |
| BusulfanAlso: Busulfex(R), Myleran(R)Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.) | Drug | Treatment |
| melphalanAlso: L-phenylalanine mustard, phenylalanine mustard, L-PAM, L-sarcolysinPatients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.) | Drug | Treatment |
| stem cellsAlso: HSCT, Stem cell transplantationPatients undergo CD3 depleted haploidentical hematopoietic stem cell transplant (HSCT) on day 0. Patients also undergo CD45RA depleted HSCT infusion on day 1. (Day 0 = stem cell transplantation.) | Biological | Treatment |
| 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 | Treatment |
Primary outcome
Feasibility of haploidentical HSCT
Time frame: 30 days post transplantation
Feasibility is defined as engraftment (ANC≥ 500/mm3 for 3 consecutive tests performed on different days) evaluated before day +30.
4 secondary outcomes
hematopoietic cell recovery and engraftment rates
Time frame: 30 days post transplantation
infection rates and complications
Time frame: up to 5 years
overall survival (OS)
Time frame: up to 1 year after transplantation
event-free survival
Time frame: up to 1 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 6 Feb 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Ewing Sarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
Not yet recruitingPhase 1/2
Combination Immunotherapy Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
RecruitingPhase 1
International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma
High-risk GD2 Positive Ewing Sarkoma
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
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.
Brando 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 alemtuzumab, fludarabine and sirolimus in people with Ewing Sarcoma and Gastrointestinal Tumor, 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 24 inclusion and 10 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 6 Feb 2026. 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?
Feasibility of haploidentical HSCT (time frame: 30 days post 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 6 Feb 2026.