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CompletedNCT00118287Updated May 24, 2017Results posted

Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

A Phase 1/2 interventional study of azacitidine and etanercept in de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes and Secondary Myelodysplastic Syndromes, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-24.

Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

PRIMARY OBJECTIVES:

I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept.

II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and for the purpose of this trial are considered as having progressive or "more advanced" disease.

III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional disease characteristics with in vivo treatment responses, to identify parameters that are associated with a high probability of response.

OUTLINE:

Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

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Conditions studied

  • de Novo Myelodysplastic Syndromes
  • Previously Treated Myelodysplastic Syndromes
  • Secondary Myelodysplastic Syndromes
03

In context

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 546 studies on the registry; 79 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.

Browse Fred Hutchinson Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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] \< 1500/μL, hemoglobin [Hgb],10g/dL, or platelet count \< 100,000/μL); or
    • Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period
  • Serum creatinine =\< 1.5x ULN (upper limit of normal)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2x ULN
  • Performance status =\< 2 (Eastern Cooperative Oncology Group [ECOG] scale, 0-5)

Exclusion criteria

Exclusion Criteria:

  • Patients who have previously received hematopoietic stem cell transplants, specifically for MDS
  • Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e >= 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Treatment (chemotherapy, chemoprotection)

    Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

    Drug: azacitidine · Biological: etanercept

Interventions

  • Drugazacitidine

    Given SC or IV

    Also known as: 5-AC, 5-azacytidine, azacytidine, Vidaza

  • Biologicaletanercept

    Given SC

    Also known as: Enbrel, ETN, TNFR:Fc, Tumor Necrosis Factor Receptor IgG Chimera

06

What researchers measure

Primary outcomes

  1. Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria

    Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.

    Time frame: Up to 2 years

07

Results

Posted May 24, 2017

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Chemotherapy, Chemoprotection)
Started32
Completed30
Not completed2
Withdrew: Intracranial haemorrhage1
Withdrew: Muscle pain1

Outcome measures

PrimaryFrequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria

Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.

Time frame:
Up to 2 years
Reported as:
Count of participants · Participants
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
ParticipantsTreatment (Chemotherapy, Chemoprotection)
Erythroid response14
Platelet response8
Neutrophil response1
No response7
Withdrawn from study2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Chemotherapy, Chemoprotection)—5/32 (15.6%)26/32 (81.3%)
Most frequent serious events
Most frequent serious events
EventTreatment (Chemotherapy, Chemoprotection)
CNS hemorrhagesNervous system disorders3/32
PneumoniaRespiratory, thoracic and mediastinal disorders1/32
Hemoptysis and feverRespiratory, thoracic and mediastinal disorders1/32
Cardiopulmonary arrest resulting in deathCardiac disorders1/32
Splenic rupture with splenectomyBlood and lymphatic system disorders1/32
Gall Bladder removal with benign massHepatobiliary disorders1/32
Pulmonary noduleRespiratory, thoracic and mediastinal disorders1/32
EndocarditisInfections and infestations1/32
DyspneaRespiratory, thoracic and mediastinal disorders1/32
Most frequent other events
Showing 10 of 44
Most frequent other events
EventTreatment (Chemotherapy, Chemoprotection)
AnemiaBlood and lymphatic system disorders19/32
NeutropeniaInvestigations17/32
ThrombocytopeniaInvestigations17/32
LymphopeniaBlood and lymphatic system disorders16/32
LeukopeniaBlood and lymphatic system disorders15/32
FatigueGeneral disorders11/32
Musculoskeletal painMusculoskeletal and connective tissue disorders11/32
HematuriaHepatobiliary disorders9/32
HyponatremiaMetabolism and nutrition disorders8/32
Febrile neutropeniaBlood and lymphatic system disorders7/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Chemotherapy, Chemoprotection)
Median69 (31 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Chemotherapy, Chemoprotection)
Female11
Male21
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Chemotherapy, Chemoprotection)
Hispanic or Latino0
Not Hispanic or Latino31
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Chemotherapy, Chemoprotection)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American1
White30
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00118287
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Bart Scott (Principal Investigator, Fred Hutchinson Cancer Center) — Principal investigator
First posted
Jul 11, 2005
Start date
Apr 2005
Primary completion
Oct 2008
Results posted
May 24, 2017
Last update
May 24, 2017

Study contacts

Bart Scott
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Azacitidine · Etanercept

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