Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Jun 10, 2014
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on finding a treatment for patients who experience graft failure after a hematopoietic stem cell transplant, which is a procedure to help treat certain blood disorders. Graft failure occurs when the new stem cells do not successfully grow and produce healthy blood cells. The treatment being studied includes a combination of medications and low-dose total body radiation, and it aims to help the donor's cells establish themselves in the patient's body by about 6 weeks after the initial transplant.
To be eligible for this trial, patients must have experienced either primary graft failure, where the new stem cells did not start producing enough blood cells by a certain time, or secondary graft failure, where the cells initially worked but later stopped. Additionally, patients should have acceptable organ function and not have any uncontrolled infections. If you or a loved one meets these criteria, you may consider participating in this study, where you can expect close monitoring and support from the medical team throughout the process.
Gender
ALL
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.
About Masonic Cancer Center, University Of Minnesota
The Masonic Cancer Center at the University of Minnesota is a leading institution dedicated to cancer research, treatment, and prevention. As a National Cancer Institute-designated Comprehensive Cancer Center, it integrates innovative research with clinical practice to enhance patient care and advance medical knowledge. The center fosters collaboration among scientists, clinicians, and educators, focusing on multidisciplinary approaches to tackle the complexities of cancer. Through its commitment to cutting-edge clinical trials, the Masonic Cancer Center aims to translate scientific discoveries into effective therapies, ultimately improving outcomes for cancer patients locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Patients applied
Trial Officials
Troy C Lund, MD, PhD
Principal Investigator
University of Minnesota
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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