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A Phase II Randomized Study Comparing Low Dose Alemtuzumab and Cyclosporine With Standard of Care for the Prevention of Chronic Extensive GVHD for Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Hematological Malignancies


Phase 2
16 Years
70 Years
Open (Enrolling)
Both
Graft Versus Host Disease, Bone Marrow Transplantation

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Trial Information

A Phase II Randomized Study Comparing Low Dose Alemtuzumab and Cyclosporine With Standard of Care for the Prevention of Chronic Extensive GVHD for Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Hematological Malignancies


Inclusion Criteria:



- Diagnosis of a hematological malignancy

- Peripheral blood as source of stem cells

- Able to give informed consent

- Availability of 6/6 matched sibling donor

- Fit for transplant using a conventional or reduced intensity approach

Exclusion Criteria:

- AST/ALT >3 x IULN at the time of transplant

- Serum creatinine > 1.5 x IULN at the time of transplant

- Prior allogeneic transplant

- Syngeneic donor

- Active uncontrolled infection

- HIV positive

- Pregnancy at the time of BMT

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Chronic extensive GVHD at 1-year (yes vs. no)

Outcome Time Frame:

12 months from the date of transplant

Safety Issue:

Yes

Principal Investigator

Vikas Gupta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Heath Network

Authority:

Canada: Health Canada

Study ID:

UHN REB 07-0436C

NCT ID:

NCT00775632

Start Date:

October 2008

Completion Date:

September 2012

Related Keywords:

  • Graft Versus Host Disease
  • Bone Marrow Transplantation
  • Graft Versus Host Disease
  • Alemtuzumab
  • Campath
  • Bone Marrow Transplants
  • Graft vs Host Disease

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