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

Sponsor
Henry Ford Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT03850366
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
81.8
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen
Actual Study Start Date :
Mar 8, 2016
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bortezomib

Drug: Bortezomib
GVHD prophylaxis
Other Names:
  • cyclophosphamide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. engraftment rate [within 30 days post transplant]

      rate of neutrophil and platelet engraftment post stem cell transplant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henry Ford hospital Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Henry Ford Health System

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shatha Farhan, Principal Investigator, Henry Ford Health System
    ClinicalTrials.gov Identifier:
    NCT03850366
    Other Study ID Numbers:
    • 10313
    First Posted:
    Feb 21, 2019
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms
    Cyclophosphamide
    Bortezomib

    Study Results

    No Results Posted as of Dec 27, 2021