NCT02161783 Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
| NCT ID | NCT02161783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Primary Graft Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2014-10-06 |
| Primary Completion | 2032-01-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2014-10-06 with a primary completion date of 2032-01-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure. The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.
Eligibility Criteria
Inclusion Criteria: * Patients with primary or secondary graft failure, as defined below, may receive a second transplant: * Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant. * Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery. * Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood. * Recipients should have acceptable organ function defined as: * Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments. * Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal * Cardiac: left ventricular ejection fraction \> 40% Exclusion Criteria: * Uncontrolled infection at the time of transplant. * Patients with Fanconi Anemia or other DNA breakage syndromes.
Contact & Investigator
Troy C Lund, MD, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT02161783 clinical trial?
This trial is open to participants of all sexes, studying Primary Graft Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02161783 currently recruiting?
Yes, NCT02161783 is actively recruiting participants. Contact the research team at tkrepsk1@fairview.org for enrollment information.
Where is the NCT02161783 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT02161783 clinical trial?
NCT02161783 is sponsored by Masonic Cancer Center, University of Minnesota. The principal investigator is Troy C Lund, MD, PhD at University of Minnesota. The trial plans to enroll 50 participants.