Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Pati… (NCT06013423) | Clinical Trial Compass
RecruitingPhase 2
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases
United States54 participantsStarted 2024-07-23
Plain-language summary
This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.
Who can participate
Age range
6 Months – 65 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 aged 6 months to =\< 65 years at time of consent.
* Acute myelogenous leukemia (AML):
* Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \< 5% marrow blasts at the time of transplant.
* Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.
* Acute lymphoblastic leukemia (ALL):
* Complete first remission (CR1) at high risk for relapse such as any of the following:
* Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.
* Failure to achieve MRD- complete remission after induction therapy.
* Persistence or recurrence of minimal residual disease on therapy.
* Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician.
* Other high-risk features not defined above.
* Complete second remission (CR2) or greater (CR2+).
* Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.
* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.
* Chronic Myeloid Leukemia (CML): Excludin…
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.
1This trial uses cord blood from a donor instead of bone marrow or peripheral blood stem cells — can you explain why cord blood might be chosen for my specific diagnosis, and what the trade-offs are compared to other donor sources?
2Since this is a Phase 2 trial, what do we already know about the safety of combining cyclophosphamide, fludarabine, and total-body irradiation as a conditioning regimen, and what risks are still being worked out at this stage?
3The trial is measuring overall survival as its main outcome — does that mean there's still meaningful uncertainty about whether this approach extends life compared to standard transplant options for my condition?
4Total-body irradiation is a significant part of this treatment — what are the short- and long-term side effects I should understand before deciding whether this trial fits my situation?
5Given that my diagnosis falls under 'high-risk hematologic disease,' would you recommend pursuing standard-of-care treatment first, or is there a reason this trial might be worth considering at this point in my care?
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.