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

NCT ID: NCT03850366

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-08
• Study Completion Date: 2027-01-01

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bortezomib

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

GVHD prophylaxis

Interventions

Bortezomib

GVHD prophylaxis

Intervention Type: DRUG

Other Intervention Names

cyclophosphamide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Shatha Farhan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford hospital

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

shatha farhan

Role: CONTACT

sfarhan1@hfhs.org

313 713 3910

Facility Contacts

shatha farhan

Role: primary

313-916-5002

Other Identifiers

10313

Identifier Type: -

Identifier Source: org_study_id