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LeukemiaPhase 2NCT00217386

Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

A Phase 2 study testing anti-thymocyte globulin and etanercept in people with Leukemia and Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
anti-thymocyte globulin and etanercept
How many people
30 participants
Where
4 sitesUnited States
Study dates
Mar 2004to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Diagnosis of myelodysplastic syndromes (MDS)
  • Low- or intermediate-1-risk disease, as defined by International Prognostic Scoring System (IPSS) criteria, meeting 1 of the following criteria:
  • Single or multilineage cytopenia, as defined by all of the following:
  • Absolute neutrophil count < 1,500/mm^3
  • Hemoglobin < 10 g/dL
  • Platelet count < 100,000/mm^3
  • Transfusion requirement of ≥ 2 units of packed red blood cells within an 8-week period
  • Not eligible for stem cell transplantation due to any of the following reasons:
  • No suitable bone marrow donor available
  • Not eligible for a transplantation protocol
  • Not willing to undergo transplantation
  • No intermediate-2- or high-risk MDS
  • No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

Pulmonary

  • No pneumonia within the past 2 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other severe disease that would preclude study compliance
  • No other active severe infection (e.g., septicemia) within the past 2 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS
  • More than 4 weeks since prior immunomodulatory therapy for MDS
  • No prior anti-thymocyte globulin
  • No prior hematopoietic stem cell transplantation
  • No other concurrent immunomodulatory therapy for MDS

Chemotherapy

  • Not specified

Endocrine therapy

  • Prednisone < 5 mg/day allowed

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS
  • More than 4 weeks since prior experimental therapy for MDS
  • No other concurrent experimental therapy for MDS

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225-1898

  • Olympic Medical Center

    Port Angeles, Washington, 98362

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.

Read the detailed description

OBJECTIVES:

  • Determine the response rate in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept.
  • Correlate ex vivo and in vitro phenotypic, cytogenetic, and functional disease characteristics with in vivo response in patients treated with this regimen.
  • Determine parameters that are associated with a high probability of response or non-response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive anti-thymocyte globulin IV over 8 hours on days 1-4. Patients also receive etanercept subcutaneously on days 8, 11, 15, and 18. Treatment with etanercept repeats every 28 days for at least 2 courses. Patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity. Patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Being tested
anti-thymocyte globulin, etanercept
Keywords
de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, myelodysplastic/myeloproliferative disease, unclassifiable, atypical chronic myeloid leukemia
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Myeloproliferative Disorders, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-thymocyte globulinBiological

  • etanerceptBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

  2. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses

  3. Identify parameters that are associated with a high probability of response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startMar 2004
  3. Primary completionDec 2007

Resources

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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217386
Sponsor's protocol ID
1872.00
Other IDs
FHCRC-1872.00, CDR0000430702
Status last verified
Sep 2010
First submitted
20 Sep 2005
Last updated
15 Sep 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-thymocyte globulin and etanercept in people with Leukemia and Myelodysplastic Syndromes, run by Fred Hutchinson Cancer Center at 4 sites 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?

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 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217386.

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 15 Sep 2010.

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