A Phase 1 interventional study of alemtuzumab and fludarabine in Ewing Sarcoma, Gastrointestinal Tumor and Germ Cell Tumor, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by St. Jude Children's Research Hospital · Phase 1, Interventional, and Treatment
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.
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:
Secondary Objectives:
287 studies on the registry are indexed under Sarcoma, Ewing; 66 are open to participants now.
This study's enrollment of 23 is below the median of 40 across 225 interventional studies indexed under Sarcoma, Ewing.
Browse Sarcoma, Ewing studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Transplant Recipients:
Histologically confirmed solid tumor or lymphoma at original diagnosis:
Exclusion Criteria - Transplant Recipients:
Inclusion Criteria - Donors:
Exclusion Criteria - Donors:
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.
Drug: alemtuzumab · Drug: fludarabine · Drug: sirolimus · Drug: Busulfan · Drug: melphalan · Biological: stem cells · Device: CliniMACS
Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation).
Also known as: CAMPATH-1H, Campath(R)
Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.)
Also known as: Fludara(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.
Also known as: Rapamycin, Rapamune(R)
Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.)
Also known as: Busulfex(R), Myleran(R)
Patients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.)
Also known as: L-phenylalanine mustard, phenylalanine mustard, L-PAM, L-sarcolysin
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.)
Also known as: HSCT, Stem cell transplantation
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.
Also known as: Cell Selection System
Feasibility of haploidentical HSCT
Feasibility is defined as engraftment (ANC≥ 500/mm3 for 3 consecutive tests performed on different days) evaluated before day +30.
Time frame: 30 days post transplantation
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.
Time frame: 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.
Time frame: up to 5 years
overall survival (OS)
Defined based on any death. The Kaplan-Meier Estimate will be provided.
Time frame: up to 1 year after transplantation
event-free survival
The Kaplan-Meier Estimate will be provided.
Time frame: up to 1 year after transplantation
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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