de Novo Myelodysplastic SyndromesPhase 1/2NCT00118287
Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
A Phase 1/2 study testing azacitidine and etanercept in people with de Novo Myelodysplastic Syndromes and Previously Treated Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes
- What is being tested?
- azacitidine and etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.
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:
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azacitidineDrug
Also called 5-AC, 5-azacytidine, azacytidine, Vidaza
Given SC or IV
etanerceptBiological
Also called Enbrel, ETN, TNFR:Fc, Tumor Necrosis Factor Receptor IgG Chimera
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemotherapy, chemoprotection) | Experimental | 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. Receives: Drug: azacitidine; Biological: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for de Novo Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bart Scott, Fred Hutchinson Cancer Center
- Investigators
- Bart Scott, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118287
- Sponsor's protocol ID
- 1926.00
- Other IDs
- NCI-2011-01818
- Status last verified
- Apr 2017
- First submitted
- 8 Jul 2005
- Last updated
- 24 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.
- ClinicalTrials.gov ID
- NCT00118287
- Acronym / sponsor ID
- 1926.00
- Conditions
- de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2005
- Primary completion
- Oct 2008 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemotherapy, chemoprotection) | Experimental | Drug: azacitidine, Biological: etanerceptPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Int-2 or high risk MDS patients
- Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with:
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azacitidineAlso: 5-AC, 5-azacytidine, azacytidine, VidazaGiven SC or IV | Drug | Treatment (chemotherapy, chemoprotection) |
| etanerceptAlso: Enbrel, ETN, TNFR:Fc, Tumor Necrosis Factor Receptor IgG ChimeraGiven SC | Biological | Treatment (chemotherapy, chemoprotection) |
Primary outcome
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Time frame: Up to 2 years
Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
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Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
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Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Scott principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing azacitidine and etanercept in people with de Novo Myelodysplastic Syndromes and Previously Treated Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.