Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants
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|ClinicalTrials.gov Identifier: NCT01881334|
Expanded Access Status : Available
First Posted : June 19, 2013
Last Update Posted : November 15, 2022
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|Condition or disease||Intervention/treatment|
|Hematologic Malignancies Inborn Errors of Metabolism Disorders Immune Deficiencies||Biological: CliniMACS CD34 Reagent System|
|Study Type :||Expanded Access|
|Official Title:||A Compassionate Release Protocol: Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Allogeneic Transplantation Using a Related Haplo-Identical Donor and Unrelated, Umbilical Cord Blood Donor(s) for the Treatment of High Risk Malignancies or Non-Malignant Disorders Requiring Allogeneic Transplantation|
- Biological: CliniMACS CD34 Reagent System
The CliniMACS CD34 Reagent System is a medical device that is used in vitro to select and enrich CD34+ cells from heterogeneous hematologic cell populations for transplantation in cases where this is clinically indicated.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||up to 65 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Have a consenting related haplo-identical (3/6, 4/6, or 5/6 if DRB1 mismatch) stem cell donor.
- Have one or two available 4, 5, or 6/6 antigen matching unrelated UCB unit(s) that will deliver a total cell dose >3.0 x 10e7 cells/kg. Patients who do not have a single UCB unit that will deliver the minimum required cell dose, two partially HLA-matched UCB units which together meet the minimum cell dose requirement, can be used for 1 transplant. These units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci with the patient, and HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of HLA typing as indicated above). There is no limitation on maximum cell dose.
- Have a high risk or refractory malignancy, or non-malignant disorder amenable to stem cell transplantation therapy.
- Meet eligibility requirements for allogeneic transplant per institutional standard practices.
- Have given written informed consent according to FDA guidelines (or consent of parent/legal guardian as applicable).
- Be <65 years of age at the time of study enrollment.
- Have a consenting 8/8 or 10/10 allele matched, consenting, related or unrelated hematopoietic stem cell transplant (HSCT) donor.
- Have a life expectancy of less than 3 months.
- Have uncontrolled infections at time of cytoreduction.
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): NCT01881334
|Contact: Erin Arbuckleemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Available|
|Durham, North Carolina, United States, 27710|
|Contact: Erin Arbuckle firstname.lastname@example.org|
|Principal Investigator: Joanne Kurtzberg, MD|
|Principal Investigator:||Joanne Kurtzberg, MD||Duke University|
|Responsible Party:||Joanne Kurtzberg, MD, MD, Duke University|
|Other Study ID Numbers:||
|First Posted:||June 19, 2013 Key Record Dates|
|Last Update Posted:||November 15, 2022|
|Last Verified:||November 2022|
T-cell depleted Stem Cells
Umbilical Cord Blood Donor
High Risk Malignancies
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Severe Aplastic Anemia
Sickle Cell Disease
Metabolism, Inborn Errors
Immunologic Deficiency Syndromes
Neoplasms by Site
Immune System Diseases
Genetic Diseases, Inborn