Phase 2
N=32
Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes · Previously Treated Myelodysplastic Syndromes · Secondary Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00118287 ↗Enrolled (actual)
32
Serious AEs
15.6%
Results posted
May 2017
Primary outcome: Primary: Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria — 14; 8; 1; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- azacitidine (Drug); etanercept (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria |
14; 8; 1; 7; 2 | — |
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
Eligibility Criteria
Inclusion Criteria
- Int-2 or high risk MDS patients
- Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with:
- Single or multilineage cytopenia (absolute neutrophil count [ANC] = 20% blasts) at time of enrollment
- Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
- Men who are unwilling to use contraception while receiving 5-aza
- Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol
- Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment
- Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS
- Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure
- Platelet count =< 10,000/mcl
- Absolute neutrophil count =< 250/mcl
- Prior treatment with 5-aza
- Known or suspected hypersensitivity to azacitidine or mannitol
Data sourced from ClinicalTrials.gov (NCT00118287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.