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

NCT ID: NCT00670423

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-16
• Study Completion Date: 2013-10-16

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.

Conditions

Graft vs Host Disease; Peripheral Blood Stem Cell Transplantation; Transplantation, Homologous

Study Design

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

Interventions

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)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Prograf®; Rapamune®; Velcade®

Eligibility Criteria

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

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

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Jennifer E. Schwartz

OTHER

Sponsor Role: lead

Responsible Party

Jennifer E. Schwartz

Assistant Professor of Clinical Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0803-17

Identifier Type: OTHER

Identifier Source: secondary_id

IUCRO-0204

Identifier Type: -

Identifier Source: org_study_id