Clinical trial · Interventional
GM-CSF Vaccinations After Allogeneic Blood Stem Cell Transplantation in Patients With Advanced Myeloid Malignancies
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 leukemia 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndrome RAEB-I or RAEB-II | — | UNRESOLVED | — |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Refractory CML Myeloid Blast Crisis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF secreting leukemia vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility as measured by ability to generate sufficient vaccine, and ability for this patient population to initiate vaccination between day 30 to day 45 after transplant.
- timeFrame
- 3 years
Secondary outcomes (3)
- measure
- Safety of GVAX vaccination as measured by grade III-IV acute GVHD, and CTC grade 3 or higher non-hematologic toxicity
- timeFrame
- 3 years
- measure
- biologic activity of GVAX vaccination
- timeFrame
- 3 years
- measure
- disease free and overall survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDHo VT, Vanneman M, Kim H, Sasada T, Kang YJ, Pasek M, Cutler C, Koreth J, Alyea E, Sarantopoulos S, Antin JH, Ritz J, Canning C, Kutok J, Mihm MC, Dranoff G, Soiffer R. Biologic activity of irradiated, autologous, GM-CSF-secreting leukemia cell vaccines early after allogeneic stem cell transplantation. Proc Natl Acad Sci U S A. 2009 Sep 15;106(37):15825-30. doi: 10.1073/pnas.0908358106. Epub 2009 Aug 26. PMID 19717467