At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of 5-Azacitidine (5AC) in Combination With Sargramostim (GM-CSF) as Maintenance Treatment, After Definitive Therapy With Either Stem Cell Transplant (SCT) or Cytarabine-based Chemotherapy, in Patients With Poor-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Oct 4, 2012·Updated Oct 18, 2022
In Brief
A Phase 2 clinical trial evaluating Azacitidine and Sargramostim for Acute Myeloid Leukemia and Myelodysplastic Syndrome. Completed, enrolled 25 participants across 1 site.
Detailed Summary
To determine the impact of maintenance therapy in patients with MDS/AML in remission.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartJun 2013
Primary CompletionJun 2020
TodayJul 2026
First PostedOct 4, 2012
Enrollment StartJun 1, 2013
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 13.7 years ago
Interventions
Azacitidinedrug
Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.
Sargramostimbiological
Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles.