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Myelodysplastic Syndrome - Healing Genes
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Myelodysplastic Syndrome

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GVAX vs. Placebo for MDS/AML After Allo HSCT

A Randomized Placebo-controlled Phase II Trial of Irradiated, Adenovirus Vector Transferred GM-CSF Secreting Autologous Leukemia Cell Vaccination (GVAX) Versus Placebo Vaccination in Patients With Advanced MDS/AML After Allogeneic Hematopoietic Stem Cell Transplantation


Phase 2

DESCRIPTION:
Researchers at Dana-Farber Cancer Institute and 3 other centers in MA seek participants to trial how an investigational intervention, the GVAX vaccine, works in preventing MDS, CMML, or AML from relapsing after allogeneic stem cell transplantation. This clinical trial is designed to assess whether adding a leukemia vaccine early after stem cell transplantation could stimulate donor cells to fight cancer and improve transplant outcomes. GVAX, a vaccine made from the patient’s own cancer cells, is engineered to produce a protein called GM-CSF that stimulates immune response specific to that cancer. GM-CSF is a naturally occurring hormone in the body that helps the immune system fight infections and diseases. The vaccine is made in the laboratory by using a virus shell to insert the GM-CSF gene into tumor cells. The cells are then irradiated, which prevents them from being able to grow, before being administered to patients in a series of vaccinations.

The study requires GVAX (or placebo, you will not know which) to be injected several scheduled times post stem cell transplant, with follow up for 2 years.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis of AML, CMML-with excess blasts, MDS-RAEB not in remission prior to leukemia cell harvest
  • Be HIV-negative
  • Not be pregnant or breastfeeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate
  2. 30 to 45 days after the already-scheduled allogeneic stem cell transplant has taken place, including drugs to prevent graft-versus-host-disease, GVAX will be injected once or more.
  3. Follow up including imaging and lab assessments will continue for up to 2 years.

LOCATIONS AND CONTACTS:
The study sites are
Massachusetts General Hospital in Boston, MA, Map.
Brigham and Women’s Hospital in Boston, MA, Map.
Dana-Farber Cancer Institute in Boston, MA, Map.
Beth Israel Deaconess Medical Center in Boston, MA, Map.

Contact:
Vincent Ho, MD  |  6176325938  |  [email protected]
 
SPONSOR INFORMATION:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT01773395

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