Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Tr… (NCT03626285) | Clinical Trial Compass
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Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders
United States
Plain-language summary
This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.
Who can participate
Age range
70 Years
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.
Inclusion Criteria:
* Patients with malignant or nonmalignant diseases that can benefit from alternative stem cell transplantation according to institutional standard practice guidelines
* Patients lacking a healthy human leukocyte antigen (HLA)-identical related donor and having one of the following alternative donor sources:
* HLA-haploidentical related (HLA antigen genotypic match \>= 4/8 and \<= 7/8) or
* Unrelated donor that is HLA matched at \>= 7/8 HLA antigen loci
* The selected donor must also be:
* Able to receive granulocyte colony-stimulating factor (G-CSF, filgrastim) and undergo apheresis either through placement of peripheral or temporary central venous catheter, based on institutional guidelines for peripheral blood stem cell collection
* Meet all institutional standard criteria for clearance for peripheral stem cell collection
* Recipients must meet institutional treatment standards based on pre-transplant evaluations including:
* Adequate major organ functions
* Free of major systemic infections
* Not pregnant, if female of childbearing age (post-pubertal)
* Recipient (if \>= 18 years) or their parent/legal guardian (if \< 18 years) must be able to sign the informed consent form for the treatment plan; assent will be obtained from recipients 7-17 years of age, in accordance to our institutional guidelines
Exclusion Criteria:
* Patients not meeting clearance criteria for bone marrow transplantation (BMT) based on standard institutional gui…
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.