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

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ClinicalTrials.gov Identifier: NCT00670423
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : February 25, 2016
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jennifer E. Schwartz, Indiana University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Peripheral Blood Stem Cell Transplantation Transplantation, Homologous Drug: Tacrolimus Drug: Sirolimus Drug: Bortezomib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
Study Start Date : May 2008
Primary Completion Date : July 2012
Study Completion Date : October 2013

Intervention Details:
    Drug: Tacrolimus
    Tacrolimus as a continuous IV infusion will begin on day -3. (Levels will be monitored at least every 3 days to target 5-10 ng/mL)
    Other Name: Prograf®
    Drug: Sirolimus
    Sirolimus oral loading dose on day -3, followed by oral daily dose. (Levels will be monitored at least every 3 days to target 3-12 ng/mL)
    Other Name: Rapamune®
    Drug: Bortezomib

    Administered intravenously on day 0 (a minimum of 6 hours post-infusion of PBSC), and on day +3. The following dose levels will be used:

    Cohort 1 (3-6 pts): 1 mg/m2 on days 0 and +3

    Cohort 2 (3-6 pts): 1.3 mg/m2 on days 0 and +3

    Cohort 3 (3-10 pts): 1.6 mg/m2 on days 0 and +3

    Other Name: Velcade®

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To assess the toxicity of bortezomib [ Time Frame: Baseline through end of study ]
  2. To describe engraftment [ Time Frame: Baseline through end of study ]
  3. To describe the incidence of acute and chronic GVHD [ Time Frame: Baseline through end of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670423

United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Jennifer E. Schwartz
Millennium Pharmaceuticals, Inc.
Principal Investigator: Jennifer Schwartz, MD Indiana University School of Medicine

Responsible Party: Jennifer E. Schwartz, Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT00670423     History of Changes
Other Study ID Numbers: 0803-17; IUCRO-0204
First Posted: May 1, 2008    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Jennifer E. Schwartz, Indiana University:
Acute Graft Versus Host Disease
Allogeneic Peripheral Blood Stem Cell Transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents