A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation

August 14, 2018 updated by: Jennifer E. Schwartz

A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation

The purpose of this study is determine the highest dose of bortezomib, a new drug for graft-versus host disease prevention, that can be given in combination with sirolimus and Tacrolimus, without causing severe side effects. This research is being done because there is no treatment that is 100% effective in preventing graft versus host disease.

The goals of this study are to:

  1. Collect peripheral blood stem cells (PBSCs) from donors for transplant.
  2. Determine the largest possible dose of bortezomib that can be given to recipients with various blood cancers in a safe manner.
  3. Monitor the recipient for risk of infection or side affects associated with the transplant.
  4. Monitor the recipient for increased immunity following transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing myeloablative peripheral blood stem cell transplantation
  • Have an HLA matched-related or matched-unrelated donor (9/10 antigen or allelic mismatch or 10/10 HLA match permitted).
  • Hematological malignancy including patients with: AML, ALL, NHL, Hodgkin's Disease, CLL, CML, MDS and Multiple Myeloma
  • Meeting institutional standard criteria for allogeneic PBSC transplantation

Exclusion Criteria:

  • Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
  • History of autologous or allogeneic transplantation
  • Evidence of HIV seropositivity
  • Evidence of active infection
  • Patients with cardiac dysfunction as described in the protocol
  • Patients with hypersensitivity to bortezomib, boron or mannitol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation.
Time Frame: Baseline through end of study
Baseline through end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the toxicity of bortezomib
Time Frame: Baseline through end of study
Baseline through end of study
To describe engraftment
Time Frame: Baseline through end of study
Baseline through end of study
To describe the incidence of acute and chronic GVHD
Time Frame: Baseline through end of study
Baseline through end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennifer E. Schwartz

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Jennifer Schwartz, MD, Indiana University School of Medicine

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 Major Dates

Study Start (Actual)

May 16, 2008

Primary Completion (Actual)

July 5, 2012

Study Completion (Actual)

October 16, 2013

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUCRO-0204
  • 0803-17 (Other Identifier: Indiana University IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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