CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
azacitidine +1 moredrug
Likely dose
Azacitidine given SC or IV; etanercept given SC (specific dose not stated)AI-extracted
Key inclusion· 6
  • ✓Int-2 or high-risk MDS by IPSS criteria
  • ✓Low-risk or Int-1 MDS with ANC <1500/μL, Hemoglobin <10 g/dL, or platelets <100,000/μL
  • ✓Transfusion requirement of ≥2 units packed red blood cells over 8 weeks (for low-risk/Int-1 patients)
  • ✓Serum creatinine ≤1.5x ULN
Key exclusion· 9
  • ✕Prior hematopoietic stem cell transplantation for MDS
  • ✕AML by WHO criteria (≥20% blasts) at enrollment
  • ✕Severe infections (pneumonia, septicemia, etc.) within 2 weeks prior to treatment start
  • ✕Prior cytotoxic therapy, growth factors, immunomodulatory therapy, or experimental therapy for MDS within 2 weeks

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00118287
NCT00118287Phase 2Completed
CompareCT.gov

Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.

Fred Hutchinson Cancer Center·interventional·Posted Jul 11, 2005·Updated May 24, 2017

In Brief

A Phase 2 clinical trial evaluating azacitidine and etanercept for de Novo Myelodysplastic Syndromes and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Conditionsde Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2005
Enrollment StartApr 1, 2005
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.0 years ago

Interventions

azacitidinedrug

Given SC or IV

etanerceptbiological

Given SC