Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (NCT04644016) | Clinical Trial Compass
RecruitingPhase 2
Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders
United States31 participantsStarted 2020-11-20
Plain-language summary
This is a single-arm study to investigate 1-year treatment related mortality (TRM) in patients with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic transplantation.
Who can participate
Age range
21 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.
Participant Inclusion Criteria:
Age and Donor Status:
Patients with age ≤ 21 years at time of consent with no available and suitably matched related or unrelated donor in the required time period.
Diagnoses :
I. Acute myelogenous leukemia (AML) :
* Complete first remission (CR1) at high risk for relapse such as any of the following:
* Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPS).
* Therapy-related AML (t-AML).
* White cell count at presentation \> 100,000.
* Presence of extramedullary leukemia at diagnosis.
* Any unfavorable subtype by FAB or WHO classification.
* High-risk cytogenetics (e.g. those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) or high-risk molecular abnormalities.
* Requirement for 2 or more inductions to achieve CR1.
* Presence of Minimal Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods after induction.
* Any patient with newly diagnosed AML with intermediate risk cytogenetics who elects allograft with curative intent over consolidation chemotherapy.
* Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.
* Other high-risk features not defined above.
* Complete second remission (CR2).
* Primary refractory or relapsed AML with less than 10% blasts by bone marrow morphology. Patients with cytogenetic, flow cytometric, or molecular abnormalities in ≤ 10% of cells are eligible.
II.…
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.
What they're measuring
1
Treatment related mortality at 1 year after myeloablative cord transplant