Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Jun 10, 2014

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.

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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.