Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Condition… (NCT01666080) | Clinical Trial Compass
RecruitingNot Applicable
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
United States30 participantsStarted 2012-08
Plain-language summary
This is a treatment guideline for a second or greater allogeneic hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) in patients with non-malignant or malignant diseases. This regimen, consisting of busulfan, fludarabine, and low dose total body irradiation (TBI), is designed to promote engraftment in patients who failed to achieve an acceptable level of donor-derived engraftment following a previous allogeneic HCT.
Who can participate
Age range
55 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 any disease for which a second or greater hematopoietic stem cell transplant is needed due to insufficient donor chimerism following hematopoietic recovery after previous HSCT. Determination of "insufficiency of donor chimerism" will be made by the treating transplant physician. Occasionally donor derived engraftment may be present, but sustained aplasia or failed recovery of sufficient hematopoiesis requires administration of a second graft. This intervention may be used for both situations.
* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
* Transplantation using sufficiently matched related donors (such as matched siblings) or unrelated donors will be considered. Both granulocyte-colony stimulating factor (GCSF) stimulated peripheral blood grafts and bone marrow grafts will be considered, although bone marrow will be the priority.
* Cord blood grafts, both related and unrelated, are also eligible. As this protocol will use a reduced intensity regimen, this protocol will use the current recommendations of the University of Minnesota for choosing cord blood grafts. If a single cord blood unit cell dose is insufficient, double cord transplantation should be considered if sufficiently matched cord blood units are available. The priority of choosing cord blood donors is based on the current institu…
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.
1Since this trial is specifically for people who have already had at least one allogeneic stem cell transplant that didn't work out, would my doctor consider me a candidate for a second transplant, and what are the main risks that come with going through this process again?
2This trial uses a reduced intensity conditioning regimen rather than a full-strength one — can my doctor explain what that actually means for my body, and why that approach might be chosen for someone receiving a second transplant?
3The trial is measuring 'time to engraftment,' meaning how quickly the donor cells take hold in my body — can my doctor help me understand what factors might affect whether engraftment succeeds this time, and what happens if it doesn't?
4Since this trial is listed as Phase NA and is still recruiting, what does my doctor know about the safety experience so far, and how does the uncertainty of an ongoing study compare to receiving standard care options I might have available?
5Given that this trial covers a range of conditions including hematologic disorders, hemoglobinopathies, and immunodeficiencies, is my specific diagnosis one where a second transplant has shown meaningful benefit, or are there other treatments my doctor would want me to try first?
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
Time to Engraftment
Timeframe: Day 42
Trial details
NCT IDNCT01666080
SponsorMasonic Cancer Center, University of Minnesota