Treatment for graft failure after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on treating graft failure following hematopoietic stem cell transplantation (HSCT) using a regimen of cyclophosphamide, fludarabine, and low-dose total body irradiation. The goal is to promote donor engraftment by day 42 after initial graft failure. The source of stem cells will be determined by the transplant team based on patient-specific factors such as age and medical history. This approach aims to provide a second chance for patients experiencing primary or secondary graft failure.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Minnesota Medical Center, Fairview
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Troy C Lund, MD, PhD — University of Minnesota
• Study coordinator: Timothy Krepski
• Email: tkrepsk1@fairview.org
• Phone: 612-273-2800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.