NCT03850366

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
20mo left

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2016Jan 2028

Study Start

First participant enrolled

March 8, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

11.8 years

First QC Date

February 20, 2019

Last Update Submit

February 23, 2026

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

  • engraftment rate

    rate of neutrophil and platelet engraftment post stem cell transplant

    within 30 days post transplant

Study Arms (1)

Bortezomib

EXPERIMENTAL
Drug: Bortezomib

Interventions

BortezomibDRUG

GVHD prophylaxis

Also known as: cyclophosphamide
Bortezomib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford hospital

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

BortezomibCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

shatha farhan

CONTACT

313 713 3910sfarhan1@hfhs.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

March 8, 2016

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

US(1)