HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen

Who is this study for? Patients with Hematological Malignancy
What treatments are being studied? Bortezomib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
Henry Ford hospital
RECRUITING
Detroit
Contact Information
Primary
shatha farhan
sfarhan1@hfhs.org
313 713 3910
Time Frame
Start Date: 2016-03-08
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 15
Treatments
Experimental: Bortezomib
Sponsors
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov

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