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GVAX for Myelodysplastic Syndrome

Phase 2
Waitlist Available
Led By Vincent Ho, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 3 years
Awards & highlights

Study Summary

This trial is testing whether a vaccine can prevent cancer from relapsing after stem cell transplantation.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
18-Month Progression Free Survival
Secondary outcome measures
18-Month Overall Survival
Percentage of Participants Experiencing Acute and Chronic Graft-Versus-Host Disease
Percentage of Participants Experiencing Grade 3 or Higher Non-Hematologic or Grade 4 or Higher Hematologic Adverse Events
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: GVAXActive Control6 Interventions
GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. GVAX arm participants meeting criteria to begin vaccinations will be administered the GVAX vaccine at established study time points.
Group II: PlaceboPlacebo Group6 Interventions
Placebo vaccine Participants in the Placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Placebo vaccine arm participants meeting criteria to begin vaccinations will be administered the placebo vaccine at established study time points.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,825 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,931 Previous Clinical Trials
13,198,322 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,107 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
GVAX vs. Placebo for MDS/AML After Allo HSCT
Vincent T. Ho, MD 2013. "GVAX vs. Placebo for MDS/AML After Allo HSCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01773395.
~10 spots leftby Apr 2025
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