Phase 2 Completed N=32 Treatment

Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

de Novo Myelodysplastic Syndromes · Previously Treated Myelodysplastic Syndromes · Secondary Myelodysplastic Syndromes

Source: ClinicalTrials.gov NCT00118287 ↗

Enrolled (actual)

Serious AEs

15.6%

Results posted

May 2017

Primary outcomePrimary: Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria — 14; 8; 1; 7 Participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria	14; 8; 1; 7; 2	—

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

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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. Informational only — not medical advice.