Second or greater stem cell transplant using reduced intensity conditioning
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
This study is testing a gentler approach to give a second or more stem cell transplant to patients with blood disorders who didn't get enough benefit from their first transplant to see if it helps them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 55 Years |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Drugs / interventions | Radiation, fludarabine |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT01666080 on ClinicalTrials.gov |
What this trial studies
This treatment guideline focuses on administering a second or greater allogeneic hematopoietic stem cell transplant (HSCT) for patients with hematologic disorders who did not achieve adequate donor-derived engraftment after a previous transplant. The approach utilizes a reduced intensity conditioning regimen that includes busulfan, fludarabine, and low-dose total body irradiation to enhance the chances of successful engraftment. The study involves the collection of routine clinical data to monitor outcomes and transplant-related endpoints, but does not include a research element beyond this data collection.
Who should consider this trial
Good fit: Ideal candidates include patients with insufficient donor chimerism following a previous hematopoietic stem cell transplant.
Not a fit: Patients who have not undergone a prior stem cell transplant or those without a suitable donor may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the chances of engraftment and recovery for patients requiring a second or greater stem cell transplant.
How similar studies have performed: Other studies have shown success with similar approaches in improving outcomes for patients undergoing multiple stem cell transplants.
Eligibility criteria
Show full inclusion / exclusion criteria
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 institutional recommendations. * Exclusion of Metabolic Disorder or other Inherited Disorder Carrier Status from related donor and unrelated cord blood grafts as appropriate for primary disease. At the discretion of the treating transplant physician, an allograft from the previous donor may be used, if available. * Age, Performance Status, Consent * Age: 0 to 55 years * Consent: voluntary written consent (adult or parental/guardian) Exclusion Criteria: * Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI). Radiation Oncology will evaluate all patients who have had previous radiation therapy or TBI for approval to receive an additional 200 cGy of TBI * Pregnant or breastfeeding * Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted * HIV positive * While it would be advantageous to begin therapy on this second transplant regimen \> 6 months following a prior myeloablative regimen or \>2 months after a reduced intensity regimen, it is recognized that there are circumstances where this may not be practical.
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Troy Lund, M.D., Ph.D. — Masonic Cancer Center, University of Minnesota
- Study coordinator: Troy Lund, M.D., Ph.D.
- Email: mill4991@umn.edu
- Phone: 612-625-2508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.