RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2016-03-08
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03850366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Candidate for stem cell transplant in a malignant hematological condition
  3. * Karnofsky Performance Scale 0-1
  4. * Available donor able to undergo a Peripheral blood stem cells collection
  5. * Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults.
  6. * Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula)
  7. * Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin.
  8. * Left ventricle ejection fraction \> 40%.
  9. * Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.
  1. * 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
  2. * HIV positive; active hepatitis B or C
  3. * Patients with active uncontrolled infections.
  4. * Liver cirrhosis
  5. * Uncontrolled central nervous system involvement by tumor cells
  6. * 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.
  7. * Inability to comply with medical therapy or follow-up

Contacts and Locations

Study Contact

shatha farhan
CONTACT
313 713 3910
sfarhan1@hfhs.org

Study Locations (Sites)

Henry Ford hospital
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-03-08
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2016-03-08
Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hematological Malignancy