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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03850366
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : December 27, 2021
Information provided by (Responsible Party):
Shatha Farhan, Henry Ford Health System

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
Hematological Malignancy Drug: Bortezomib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 8, 2016
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Bortezomib Drug: Bortezomib
GVHD prophylaxis
Other Name: cyclophosphamide

Primary Outcome Measures :
  1. engraftment rate [ Time Frame: within 30 days post transplant ]
    rate of neutrophil and platelet engraftment post stem cell transplant

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03850366

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Contact: shatha farhan 313 713 3910

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United States, Michigan
Henry Ford hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: shatha farhan    313-916-5002      
Sponsors and Collaborators
Henry Ford Health System
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Responsible Party: Shatha Farhan, Principal Investigator, Henry Ford Health System Identifier: NCT03850366    
Other Study ID Numbers: 10313
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists