Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Periphera… (NCT01529827) | Clinical Trial Compass
CompletedPhase 2
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
United States94 participantsStarted 2012-02-28
Plain-language summary
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT 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 the 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 cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening
Who can participate
Age range
3 Years – 75 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:
* Diagnosis of a histology documented hematologic malignancy or marrow disorder
BONE MARROW FAILURE DISORDERS:
* Acquired bone marrow failure disorders include aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH) \* Primary allogeneic HSCT is appropriate for selected patients with severe aplastic anemia; however, patients with aplastic anemia must have failed at least one cycle of standard immunosuppressive therapy with calcineurin inhibitor plus anti-thymocyte globulin (ATG) if a fully matched donor is available \* Patients with PNH should not be eligible for a myeloablative HSCT
* Hereditary bone marrow failure disorders include Diamond-Blackfan Anemia, Shwachman-Diamond Syndrome, Kostmann Syndrome, congenital Amegakaryocytic Thrombocytopenia; Fanconi Anemia or related chromosomal breakage syndrome, Dyskeratosis Congenital are excluded from this study die to their poor deoxyribonucleic acid (DNA) repair capacity \* Fanconi anemia or related chromosomal breakage syndrome: positive chromosome breakage analysis using diepoxybutane (DEB) or mitomycin C if applicable \* Dyskeratosis Congenita: diagnosis is supported by using either telomerase RNA component (TERC) gene mutation in autosomal dominant Dyskeratosis Congenita or X-linked DKC1 gene mutation
* Other non-malignant hematologic or immunologic disorders that require transplantation \* Quantitative or qualitative congenital platelet disorders (including but not limited to congenital amegakaryocy…
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 used a 'reduced-intensity' conditioning regimen combining fludarabine, melphalan, and low-dose total-body irradiation before a donor stem cell transplant — how does that approach compare to a full-intensity transplant for my specific diagnosis, and which might be more appropriate for me?
2The trial's main goal was to measure transplant-related mortality, meaning deaths caused by the transplant process itself rather than the disease — what does the completed data from this trial tell you about how risky this type of conditioning regimen appears to be?
3Since this trial is now completed and was a Phase 2 study, has enough safety and effectiveness data been published that you can use it to inform my treatment plan, or are we still waiting on more mature results?
4This trial covered a very wide range of blood cancers and bone marrow conditions — given my specific diagnosis, do you think the outcomes seen in patients like me in this study are relevant enough to guide a recommendation for or against this type of transplant approach?
5Because this transplant uses donor peripheral blood stem cells, graft-versus-host disease is a known risk — based on what this trial measured and reported, how would you weigh that risk against my current treatment alternatives?
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
Transplant Related Mortality (TRM)
Timeframe: In the first 100 days from day 0 of transplant