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View Clinical Trial (Medical Research Study)
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A Combination of Imatinib Mesylate and Pegylated Interferon α2a in Chronic-Phase Chronic Myeloid Leukemia - NCT00573378-48109 (Clinical Trial 195161)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy195161.aspx
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| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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Chronic Myeloid Leukemia |
| Purpose: |
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Chronic myelogenous leukemia (CML) is a slow-growing cancer of the white blood cells. CML
patients have bone marrow that makes too many white blood cells. CML is caused by a change
in the genetic code of some of the cells in the bone marrow. In these cells, part of
chromosome 9 moves to chromosome 22. This creates an abnormal chromosome called the
Philadelphia chromosome. The Philadelphia chromosome makes an enzyme (called tyrosine
kinase) that signals the body to make too many white blood cells. It is not known what
causes the Philadelphia chromosome to appear
For most patients, a drug called Gleevec is the standard first treatment. (Gleevec is also
known as imatinib mesylate.) Gleevec was approved by the U.S. Food and Drug Administration
(FDA) in 2001. Gleevec blocks the tyrosine kinase enzyme so that the body stops (or slows
down) making too many white blood cells. Although Gleevec has been effective in controlling
the leukemia in most patients with CML, we know this therapy alone is not a cure. Gleevec
does not kill the leukemic stem cells, which are a small population of cells that exist
primarily in the bone marrow, and are responsible for ongoing disease. This study will
evaluate whether the addition of a drug called pegylated interferon-α2a given with Gleevec
will better target these leukemic stem cells, causing them to die. It is hoped that by
killing the leukemia stem cells with Gleevec and interferon-α2a, patients may be able to
eventually stop all of their CML therapy, and have their leukemia remain in a remission
without having to receive treatment.
Pegylated interferon-α2a (Pegasys) is not approved by the United States Food and Drug
Administration (FDA) for the treatment of chronic myeloid leukemia (CML), but interferon-α2a
is approved for the treatment of CML and has been used extensively in the treatment of this
disease. The pegylated form of interferon-α2a (Pegasys) has also been widely studied and
shown to be an effective treatment for CML, but the manufacturer has never sought FDA
approval for this indication.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in
chronic phase by having met all of the following criteria at the time of their
initial diagnosis:
- Cytogenetic confirmation of Philadelphia chromosome or variants of (9;22)
translocations. may have secondary chromosomal abnormalities in addition to the
Philadelphia chromosome.
- Peripheral blood or bone marrow blast count < 10%.
- Peripheral blood basophil count < 20%.
- Platelet count ≥ 100,000 x 10^9/L.
- eighteen years of age or older
- must be actively receiving treatment for their CML with imatinib mesylate.
- must be on imatinib mesylate for a minimum of 2 years, and be on a stable dose for
at least one consecutive year leading up to enrollment.
- must have an ongoing complete hematologic response (CHR) on imatinib mesylate,
defined as follows:
- WBC ≤ 10 x 10^9/L.
- Platelet count < 450,000 x 10^9/L.
- No blasts or promyelocytes in peripheral blood.
- No evidence of disease-related symptoms and extramedullary disease, including
the liver and spleen.
- must have a complete cytogenetic response (CCyR) on imatinib mesylate for a minimum
of 1 year leading up to enrollment. Complete cytogenetic response is defined as 0%
Ph+ cells in metaphase, in the bone marrow and/or a negative peripheral blood FISH
analysis for the BCR-ABL gene fusion, and an ongoing CCyR must be confirmed by bone
marrow aspirate cytogenetics and/or peripheral blood FISH for BCR-ABL within 4 weeks
of starting treatment.
- may have a negative quantitative RT-PCR (QPCR) for BCR-ABL at the time time of
enrollment, but if QPCR is positive, patients cannot have greater than 0.5%
BCR-ABL/ABL transcript, present in 2 consecutive QPCR analyses, performed at least 3
months apart, in the 6 to 12 months leading up to enrollment.
- must have an ECOG performance status of 0-2.
- must be informed of the investigational nature of this study and standard alternative
therapy. Must sign and give written informed consent in accordance with
institutional and federal guidelines.
Exclusion Criteria:patients who:
- have had prior progression of their CML to accelerated phase or blast crisis.
- have previously undergone hematopoietic stem cell transplantation.
- have previously been treated with interferon-α.
- with an absolute neutrophil count (ANC) < 1500/mm3 and/or a platelet count <
100,000/mm3.
- with serum bilirubin, SGOT[AST], SGPT[ALT], or serum creatinine > 1.5 x the upper
limit of normal (ULN).
- with an INR or PTT > 1.5 x ULN, with the exception of patients on treatment with oral
anticoagulants.
- with uncontrolled medical diseases such as diabetes mellitus, neuropsychiatric
disorders, infection, angina, severe hypertension, pulmonary disease (chronic
obstructive pulmonary disease [COPD] with hypoxemia), major organ malfunction (liver,
kidney) or class III or IV cardiac disease as defined by the New York Heart
Association Criteria.
- are:
1. pregnant
2. breast feeding
3. of childbearing potential without a negative pregnancy test prior to Study Day
1, and
4. male or female of childbearing potential unwilling to use barrier contraceptive
precautions throughout the trial (postmenopausal women must be amenorrheic for
at least 12 months to be considered of non-childbearing potential).
- with a history of another active malignancy within the last five years, which
required treatment with chemotherapy, hormonal therapy, or radiation therapy.
Exceptions to this rule include basal cell and squamous cell skin carcinomas or
cervical carcinoma in situ.
- with a history of non-compliance to medical regimens or who are considered
potentially unreliable. |
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| Study is available at: |
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Universtiy of Michigan
Ann Arbor, MI 48109
United States
Primary Contact:
Lisa Kujawski, MD
Email: kuj@umich.edu
Phone: 734-764-8100
Secondary Contact:
Lisa Kujawski, MD
Email: kuj@umich.edu
Phone: 734-764-8100 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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