Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC (NCT03145545) | Clinical Trial Compass
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Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC
United States
Plain-language summary
The primary objective of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PATIENT AND DONOR ELIGIBILITY
Enrollment on this study includes patients undergoing a primary or non emergent subsequent hematopoietic stem cell transplant, an urgent subsequent transplant in the setting of graft failure or marrow aplasia, or an unconditioned stem cell boost for graft dysfunction or declining donor chimerism. Differences in eligibility criteria among these scenarios are outlined below.
Inclusion Criteria: Applicable to all Subjects
* Signed, informed consent
* Participants of childbearing potential must have a negative pregnancy test as per institutional SOP
* Patients who do not meet criteria for current open, institutional protocols using CliniMACs device for β T/CD19+ depletion
* Patients with the following transplantable diseases:
* Non-malignant diseases
* Metabolic storage diseases correctable by HSCT
* Bone marrow failure syndromes
* Immunodeficiencies/immune dysregulation syndromes
* Sickle cell disease or thalassemia
* Other diseases treated with HSCT
o Malignant diseases
* Acute leukemias
* Chronic leukemias
* Lymphomas
* Myelodyplastic syndrome
Inclusion Criteria: Primary transplant or non-emergent subsequent transplant
The conditioning prescribed to the patient will be determined based on the disease and organ status and will include agents that are standard. Appropriate combinations of chemotherapy, immunotherapy and/or radiation will be determined on an individual basis. Patient eligibility will be assessed as per …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.