Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03850366

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henry Ford hospital

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

shatha farhan

CONTACT

313-916-5002

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

GVHD prophylaxis

Other names: cyclophosphamide

Primary outcomes

  1. engraftment rate

    Time frame: within 30 days post transplant

    rate of neutrophil and platelet engraftment post stem cell transplant

Study contacts

Contact information is provided by the study sponsor or research team.

shatha farhan

CONTACT

[email protected]

313 713 3910

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2019
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.