HLA-Haploidentical Stem Cell Transplant with Cyclophosphamide and Bortezomib

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 study evaluates the effectiveness of HLA-haploidentical peripheral blood stem cell transplantation in patients with hematological malignancies who lack a suitable matched donor. It utilizes post-transplant cyclophosphamide and bortezomib to prevent graft versus host disease (GVHD) and enhance immune recovery. The goal is to assess the engraftment rate in these patients, providing a potential alternative for those without matched donors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified
* Candidate for stem cell transplant in a malignant hematological condition
* Karnofsky Performance Scale 0-1
* Available donor able to undergo a Peripheral blood stem cells collection
* Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults.
* Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula)
* Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin.
* Left ventricle ejection fraction \> 40%.
* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.

Exclusion Criteria:

* Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation
* HIV positive; active hepatitis B or C
* Patients with active uncontrolled infections.
* Liver cirrhosis
* Uncontrolled central nervous system involvement by tumor cells
* Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
* Inability to comply with medical therapy or follow-up

Where it's running

• Henry Ford hospital
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: shatha farhan
• Email: sfarhan1@hfhs.org
• Phone: 313 713 3910

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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.