Recruiting
Phase 2

HLA-Haploidentical PBSC Transplantation with Cyclophosphamide & Bortezomib

Sponsor:

Henry Ford Health System

Code:

NCT03850366

Conditions

Hematological Malignancy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Bortezomib

Study Details

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

Conditions

Hematological Malignancy

Study ID

NCT03850366

Start date

Mar 8, 2016

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bortezomib

Interventions

Bortezomib

GVHD prophylaxis

Primary outcome measure

  • engraftment rate [ Time Frame: within 30 days post transplant ]

Central Contacts and Locations

Central contacts

shatha farhan

313 713 3910sfarhan1@hfhs.org

Locations

Henry Ford hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

shatha farhan

313-916-5002

More Information

Sponsor

Henry Ford Health System

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-02-24.