HLA-Haploidentical Stem Cell Transplant with Cyclophosphamide and Bortezomib
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen
This study is testing a new stem cell transplant method for patients with blood cancers who don't have a matched donor, using special medications to help their bodies accept the transplant and recover better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT03850366 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with hematological malignancies who have a haploidentical donor but lack a matched related or unrelated donor.
Not a fit: Patients who have a suitable related or unrelated donor or cord blood units available for transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a viable transplant option for patients with hematological malignancies who currently have limited donor availability.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly in the use of post-transplant cyclophosphamide to reduce GVHD.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Detroit, Michigan
- Henry Ford hospital — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: shatha farhan
- Email: sfarhan1@hfhs.org
- Phone: 313 713 3910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.