Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT03850366

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

Led by Henry Ford Health System · Updated on 2026-02-24

15

Participants Needed

1

Research Sites

616 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 65 years
  • Lack a matched related or unrelated donor but have a related haploidentical donor identified with at least 5/10 HLA allele match
  • Eligible for stem cell transplant due to malignant hematological condition
  • Karnofsky Performance Scale score between 0 and 1
  • Available donor able to provide peripheral blood stem cells
  • Bilirubin level less than or equal to 1.5 mg/dl
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than or equal to 200 IU/ml
  • Serum creatinine clearance at least 60 ml/min (Cockroft-Gault formula)
  • Diffusing capacity for carbon monoxide (DLCO) at least 45% predicted corrected for hemoglobin
  • Left ventricle ejection fraction greater than 40%
  • Written informed consent from patient or legal representative
Not Eligible

You will not qualify if you...

  • Presence of a suitable related or unrelated donor or cord units for transplant with 8/8 or 7/8 HLA match available within 42 days of search
  • HIV positive status or active hepatitis B or C
  • Active uncontrolled infections
  • Liver cirrhosis
  • Uncontrolled central nervous system involvement by tumor cells
  • Positive Beta Human chorionic gonadotropin (HCG) test in women with childbearing potential (not post-menopausal for 12 months or no surgical sterilization)
  • Inability to comply with medical therapy or follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henry Ford hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

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Research Team

S

shatha farhan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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