The purpose of this study is to investigate whether the addition of a vaccine after participants reduced intensity transplant will be safe and beneficial. The vaccine used in this trial, called GVAX, will be made from the participants own leukaemia cells, and will be given between 1-4 months after transplant. In recent years, researchers have discovered that GVAX vaccine made from the patient’s own cancer calls that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.
Official Title
GM-CSF Secreting Leukemia Cell Vaccinations After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation in Patients With Advanced Myelodysplastic Syndrome or Refractory Acute or Advanced Chronic Myeloid Leukemia.
Conditions
- Myelodysplastic Syndrome RAEB-I or RAEB-II
- Refractory Acute Myeloid Leukaemia
- Refractory CML Myeloid Blast Crisis
Study Type
Interventional
Study Design
Treatment, Non-Randomised, Open Label, Single Group Assignment, Safety Study.
Further Details
Primary Outcome Measures:
- Feasibility as measured by ability to generate sufficient vaccine, and ability for this patient population to initiate vaccination between day 30 and day 45 after transplant.
[Time Frame: 3 years]
[Designated as safety issue: No]
Secondary Outcome Measures:
- Safety of GVAX vaccination as measured by grade III-IV acute GVHD, and CTC grade 3 or higher non-haematologic toxicity
[Time Frame: 3 years]
[Designated as safety issue: Yes] - Biologic activity of GVAX vaccination
[Time Frame: 3 years]
[Designated as safety issue: No] - Disease free and overall survival.
[Time Frame: TBD]
[Designated as safety issue: No]
Study Start
June 2004
Eligibility & Criteria
- Ages Eligible for Study: 18 years and older
-
Genders Eligible for Study: Both
Inclusion Criteria:
- AML, MDS-RAEB or RAEB-T, CML, myeloid blast crisis not in remission or CML accelerated phase. Subjects must have > 5% blasts in bone marrow or peripheral blood prior to admission for transplant.
- HLA 6/6 matched related or unrelated donor available
- ECOG Performance Statue 0-2
- 18 years of age or older
Exclusion Criteria:
- Uncontrolled infection
- Leukemia with active CNS involvement
- Serum creatinine greater than 2.0 mg/dl
- ALT or AST greater than 3 x ULN
- Total bilirubin greater than 2.0 mg/dl
- Positive HIV or HTLV-1 serology
- Prior allogeneic stem cell transplant.
Total Enrolment
24
Contact Details
Vincent Ho (MD)
Dana-Farber Cancer Institute
Location:
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
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