HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib
Primary Purpose
Hematological Malignancy
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancy
Eligibility 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
Sites / Locations
- Henry Ford hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bortezomib
Arm Description
Outcomes
Primary Outcome Measures
engraftment rate
rate of neutrophil and platelet engraftment post stem cell transplant
Secondary Outcome Measures
Full Information
NCT ID
NCT03850366
First Posted
February 20, 2019
Last Updated
December 27, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03850366
Brief Title
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib
Official Title
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
cyclophosphamide
Intervention Description
GVHD prophylaxis
Primary Outcome Measure Information:
Title
engraftment rate
Description
rate of neutrophil and platelet engraftment post stem cell transplant
Time Frame
within 30 days post transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shatha farhan
Phone
313 713 3910
Email
sfarhan1@hfhs.org
Facility Information:
Facility Name
Henry Ford hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shatha farhan
Phone
313-916-5002
12. IPD Sharing Statement
Learn more about this trial
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib
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