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RecruitingNCT03850366Updated Feb 24, 2026

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

A Phase 2 interventional study of Bortezomib in Hematological Malignancy, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Henry Ford Health System · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Mar 2016, registered Feb 2019).
  • Started Mar 2016; still recruiting 10 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hematological Malignancy
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's planned enrollment of 15 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Bortezomib

    Drug: Bortezomib

Interventions

  • DrugBortezomib

    GVHD prophylaxis

    Also known as: cyclophosphamide

06

What researchers measure

Primary outcomes

  1. engraftment rate

    rate of neutrophil and platelet engraftment post stem cell transplant

    Time frame: within 30 days post transplant

07

Study locations

1 of 1 sites recruiting
  • Henry Ford hospital
    Detroit, Michigan 48202, United States
    • shatha farhan · Contact · 313-916-5002
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03850366
Lead sponsor
Henry Ford Health System
Responsible party
Shatha Farhan (Principal Investigator, Henry Ford Health System) — Principal investigator
First posted
Feb 21, 2019
Start date
Mar 8, 2016
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Feb 24, 2026

Study contacts

shatha farhan
Contact
sfarhan1@hfhs.org
313 713 3910

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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