Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using MHC Mismatched Related Donors (STALLO)
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ClinicalTrials.gov Identifier: NCT01462396 |
Recruitment Status
: Unknown
Verified February 2015 by Children's Mercy Hospital Kansas City.
Recruitment status was: Active, not recruiting
First Posted
: October 31, 2011
Last Update Posted
: February 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroblastoma | Device: CD34+ cells selected with the Miltenyi Clinimacs machine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using Major Histocompatibility Complex (MHC) Mismatched Related Donors and Sub-Myeloablative Regimen |
Study Start Date : | October 2011 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |

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Device: CD34+ cells selected with the Miltenyi Clinimacs machine
- The immediate safety of a fludarabine based reduced intensity conditioning regimen and CD34+ stem cell selected mis-matched, related, allogeneic transplant will be assess in patients with relapsed/refractory neuroblastoma [ Time Frame: 6 weeks ]Monitoring of mortality, toxicity (NCI Common Criteria), acute and chronic graft versus host disease, engraftment rate will contribute to safety assessment
- Infusional and long term safety and persistence of tumor redirected, genetically modified, donor derived, allogeneic multi-virus specific cytotoxic T-cells (tV-CTL) after allogeneic hematopoietic stem cell transplant in patients with neuroblastoma [ Time Frame: 4-8 weeks post transplant ]Tumor evaluation will occur 4-8 weeks after transplant

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Ages Eligible for Study: | 6 Months to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 6 months - <18 years
- Measurable tumor by routine imaging or bone marrow biopsy
- Patient must have an 3/6, 4/6, or 5/6 human leukocyte antigen (HLA)-mismatched related donor who is Epstein-Barr virus (EBV) seropositive
- Karnofsky score 60% or greater if 10yrs old or older, Lansky score 60% or greater if under 10yrs old
- Pulse ox >90% on room air
- Recovered from toxic effects of prior chemotherapy
- Patient must not be pregnant
- Patient must be HIV negative
- Patient or responsible person must be able to understand and sign an informed consent
- Available donor without contraindication for stem cell collection
Exclusion Criteria:
- Pregnant and lactating women.
- Human immunodeficiency virus (HIV) positive patient.
- Uncontrolled intercurrent infection.
- Renal failure (Creatine > 1.5 or Creatinine Clearance < 40 ml/min/1.73m2)
- Active hepatitis or cirrhosis with liver test values greater than 3 times normal
- NOTE: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion, after review by the Children's Mercy Hospital ethics board
- Donor Inclusion/Exclusion Criteria
- Donor must be in good health based on review of systems and results of physical examination, and routine testing per standards of good medical care.
- Female donors of childbearing age must have a negative pregnancy test and must not be lactating
- EBv seropositive
- Donor stem cells should be human leukocyte antigen (HLA) typed using molecular methods. See section 6.1.3 for HLA matching requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462396
United States, Missouri | |
Children's Mercy Hospital | |
Kanas City, Missouri, United States, 64108 |
Additional Information:
Responsible Party: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT01462396 History of Changes |
Other Study ID Numbers: |
STALLO |
First Posted: | October 31, 2011 Key Record Dates |
Last Update Posted: | February 5, 2015 |
Last Verified: | February 2015 |
Keywords provided by Children's Mercy Hospital Kansas City:
Neuroblastoma Relapsed Refractory |
Additional relevant MeSH terms:
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |