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Completed

NCT Number: NCT00670423

A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) 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.

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Key information

Conditions

Graft vs Host Disease Immune System Diseases Peripheral Blood Stem Cell Transplantation Transplantation, Homologous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

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 names: Prograf®

sirolimus

Drug

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 names: Rapamune®

bortezomib

Drug

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 names: Velcade®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jennifer E. Schwartz

Other

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
May 1, 2008
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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