Chemotherapy and Total-Body Irradiation Followed by Donor Umbilical Cord Blood Transplant, Cyclos… (NCT00290641) | Clinical Trial Compass
CompletedNot Applicable
Chemotherapy and Total-Body Irradiation Followed by Donor Umbilical Cord Blood Transplant, Cyclosporine, and Mycophenolate Mofetil in Treating Patients With Hematologic Cancer
United States68 participantsStarted 2001-04
Plain-language summary
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with total-body irradiation followed by donor umbilical cord blood transplant, cyclosporine, and mycophenolate mofetil works in treating patients with hematologic cancer.
Who can participate
Age range
45 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.
DISEASE CHARACTERISTICS:
* Diagnosis of a hematologic malignancy of 1 of the following types:
* Acute myeloid leukemia (AML), meeting the following criteria:
* In complete remission (CR) by morphology (\< 5% blasts in the bone marrow), as defined by 1 of the following:
* In first CR (CR1) and meets ≥ 1 of the following high-risk criteria:
* High-risk cytogenetics (e.g., those associated with myelodysplastic syndromes \[MDS\] or complex karotype)
* Preceding MDS
* More than 2 courses of therapy was required to obtain CR
* In second or greater CR
* No morphologic relapse
* Cytogenetic relapse or persistent disease allowed
* Acute lymphocytic leukemia (ALL), meeting the following criteria:
* In CR, as defined by 1 of the following:
* In CR1 and meets ≥ 1 of the following high-risk criteria:
* Unfavorable high-risk cytogenetics \[t(9;22), t(1;19), t(4;11) or other MLL rearrangements\]
* More than 1 course of therapy was required to obtain CR
* In second or greater CR
* No morphologic relapse or persistent disease
* Chronic myelogenous leukemia (CML), excluding refractory blast crisis
* Advanced myelofibrosis
* Advanced myelodysplasia (blasts \< 10% \[otherwise need AML induction pre-transplant\]), meeting ≥ 1 of the following criteria:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Refractory anemia with severe pancytopenia
* High-ris…
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
Engraftment as measured by an absolute neutrophil count of donor origin > 0.5 x 109 /L for 3 days by day 42
Trial details
NCT IDNCT00290641
SponsorMasonic Cancer Center, University of Minnesota