HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/23/2019 |
| Start Date: | March 8, 2016 |
| End Date: | January 1, 2023 |
| Contact: | shatha farhan |
| Email: | sfarhan1@hfhs.org |
| Phone: | 313 713 3910 |
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen
Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more
feasible with better regimens to prevent graft versus host disease (GVHD) like post
transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been
shown to inhibit dendritic cells maturation and function and possesses a number of other
favorable immunomodulatory effect that can prevent GVHD and help enhance immune
reconstitution. this study is to assess the engraftment rate in patients with hematologic
malignancies who need allogeneic stem cell transplant but do not have a suitable matched
related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical
allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and
bortezomib
feasible with better regimens to prevent graft versus host disease (GVHD) like post
transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been
shown to inhibit dendritic cells maturation and function and possesses a number of other
favorable immunomodulatory effect that can prevent GVHD and help enhance immune
reconstitution. this study is to assess the engraftment rate in patients with hematologic
malignancies who need allogeneic stem cell transplant but do not have a suitable matched
related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical
allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and
bortezomib
Inclusion Criteria:
- 18-65 years old patient lacking a matched related donor or unrelated donor but have a
related haploidentical donor ( 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 (ALT)
- 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
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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