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Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Leukemia, Lymphoma, Myelodysplastic Syndrome

Thank you

Trial Information

Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study


Before your transplant you will receive conditioning therapy with fludarabine and busulfan
given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood
cells taken from your sibling or unrelated donor.

You will receive 3 drugs for your GVHD prophylaxis:

Tacrolimus will be started 3 days before your transplant. It will be given intravenously and
later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.

Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.

Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4,
7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood
work, and be asked to complete a questionnaire.


Inclusion Criteria:



- Histologically or cytologically confirmed advanced and/or aggressive hematologic
malignancy (including myelodysplastic syndrome) that is unlikely to be cured by
alternative therapies

- HLA-Matched unrelated donor; or 1-locus HLA-mismatched related or unrelated donor

- ECOG performance status 0-2

- Adequate organ function

- Able to understand and willing to sign a written informed consent document

- Agrees to practice adequate contraception per study requirements

Exclusion Criteria:

- Pregnant or breastfeeding

- Recipient of prior allogeneic or autologous stem cell transplantation

- Prior abdominal radiation therapy

- HIV-positive on combination antiretroviral therapy

- Seropositive for hepatitis B or C

- Allergies to bortezomib, boron, or mannitol

- Myocardial infarction within last 6 months, NYHA Class III or IV heart failure,
uncontrolled angina, severe uncontrolled ventricular arrhythmias

- Uncontrolled bacterial, viral or fungal infections

- Seizures or history of seizures

- History of another non-hematologic malignancy unless disease-free for at least 5
years

- Uncontrolled intercurrent illness

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the incidence of grade II-IV acute GVHD by day 100 after stem cell infusion

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

John Koreth, MBBS, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

11-007

NCT ID:

NCT01323920

Start Date:

May 2011

Completion Date:

November 2014

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndrome
  • Stem Cell Transplant
  • Allogeneic Transplant
  • Donors
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115