RECRUITING

Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.

Official Title

Allogeneic Hematopoietic Stem Cell Transplantation From an HLA-partially Matched Related or Unrelated Donor After TCR αβ+T Cells/CD19+ B Cell Depletion in Children and Young Adults Affected by Malignant or Non-Malignant Hematological Disorders

Quick Facts

Study Start:2020-02-01

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04249830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Age \< 60 years and \> 1 month; 2. Life expectancy \> 10 weeks; 3. Patients deemed eligible for allogeneic HSCT per institutional guidelines; 4. Patients with life-threatening hematological malignancies and non-malignant disorders that could benfit from HSCT; 5. A minimum genotypic identical match of 5/10 is required; 6. The donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA-DRB1; 7. Lansky/Karnofsky score \> 50; 8. Signed written informed consent; 9. Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD.	1. Pregnant or lactating females; 2. Greater than Grade II acute GvHD or severe, unmanaged chronic extensive GvHD due to a previous allograft at the time of inclusion; 3. Dysfunction of liver (ALT/AST \> 10 times upper normal value, or direct bilirubin \> 3 times upper normal value), or unmanageable dysfunction of renal function; 4. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \< 30%); 5. Current active infectious disease (including positive HIV serology or viral RNA); 6. Serious concurrent uncontrolled medical disorders; 7. Lack of patient's/parents'/guardian's informed consent; 8. Any severe concurrent disease which, in the judgement of the sponsor-investigator, would place the patient at increased risk during participation in the study.

Inclusion Criteria

Exclusion Criteria

1. Age \< 60 years and \> 1 month;
2. Life expectancy \> 10 weeks;
3. Patients deemed eligible for allogeneic HSCT per institutional guidelines;
4. Patients with life-threatening hematological malignancies and non-malignant disorders that could benfit from HSCT;
5. A minimum genotypic identical match of 5/10 is required;
6. The donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA-DRB1;
7. Lansky/Karnofsky score \> 50;
8. Signed written informed consent;
9. Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD.

1. Pregnant or lactating females;
2. Greater than Grade II acute GvHD or severe, unmanaged chronic extensive GvHD due to a previous allograft at the time of inclusion;
3. Dysfunction of liver (ALT/AST \> 10 times upper normal value, or direct bilirubin \> 3 times upper normal value), or unmanageable dysfunction of renal function;
4. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \< 30%);
5. Current active infectious disease (including positive HIV serology or viral RNA);
6. Serious concurrent uncontrolled medical disorders;
7. Lack of patient's/parents'/guardian's informed consent;
8. Any severe concurrent disease which, in the judgement of the sponsor-investigator, would place the patient at increased risk during participation in the study.

Contacts and Locations

Principal Investigator

Alice Bertaina, MD, PhD

PRINCIPAL_INVESTIGATOR

Associate Professor of Pediatrics, Stem Cell Transplantation

Study Locations (Sites)

Lucile Packard Children's Hospital

Palo Alto, California, 94306

United States

Collaborators and Investigators

Sponsor: Alice Bertaina

Alice Bertaina, MD, PhD, PRINCIPAL_INVESTIGATOR, Associate Professor of Pediatrics, Stem Cell Transplantation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-01

Study Completion Date2025-02

Study Record Updates

Study Start Date2020-02-01

Study Completion Date2025-02

Terms related to this study

Additional Relevant MeSH Terms

Hematologic Diseases