HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib

Henry Ford Health

Status and phase

Enrolling

Phase 2

Conditions

Hematological Malignancy

Treatments

Drug: Bortezomib

Study type

Interventional

Funder types

Other

Identifiers

NCT03850366

10313

Details and patient eligibility

About

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

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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