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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Graft vs Host Disease, Peripheral Blood Stem Cell Transplantation, Transplantation, Homologous

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

Baseline through end of study

Safety Issue:

Yes

Principal Investigator

Jennifer Schwartz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

0803-17; IUCRO-0204

NCT ID:

NCT00670423

Start Date:

May 2008

Completion Date:

December 2013

Related Keywords:

  • Graft Vs Host Disease
  • Peripheral Blood Stem Cell Transplantation
  • Transplantation, Homologous
  • Tacrolimus
  • Sirolimus
  • Bortezomib
  • Acute Graft Versus Host Disease
  • Allogeneic Peripheral Blood Stem Cell Transplantation
  • Graft vs Host Disease

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289