Chronic Myelogenous LeukemiaPhase 2NCT00042003
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
A Phase 2 study testing decitabine (5-aza-2'deoxycytidine) in people with Chronic Myelogenous Leukemia, run by Astex Pharmaceuticals, Inc. at 8 sites in 2 countries.
Trial summary
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- decitabine (5-aza-2'deoxycytidine)
- How many people
- 40 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2002to Dec 2004
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of CML blast phase
- Ph chromosome-positive
- Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
- Patients must have recovered from the side effects of previous CML therapy for blast phase with the exception of hydroxyurea
- Age >/= 2 years
- Bilirubin </= 3 x the upper limit of normal (ULN), SGOT and SGPT </= 3 x ULN, except </= 5 x ULN in leukemic involvement of the liver, serum creatinine </= 2 x ULN
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- WHO performance status 0-3
- A negative serum hCG pregnancy test in patients of childbearing potential
- Able to give signed informed consent directly or through a parent or guardian for minors
Who cannot join
- Leukemic involvement of the central nervous system
- Active malignancy other than CML or non-melanoma cancer of the skin
- Previous treatment for CML with another investigational agent within 28 days of study entry
- At study entry, patients who were treated with: imatinib mesylate within the past 48 hours, interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
- Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
- Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
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- Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
- Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
- Patients with systemic, uncontrolled infections
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Liberty Hematology/Oncology
Columbia, South Carolina
City of Hope Medical Center
Duarte, California
Scripps Clinic
Escondido, California
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
USC/Norris Cancer Center
Los Angeles, California
Metro-Minnesota CCOP
Saint Louis Park, Minnesota
New York Medical College
Valhalla, New York
About this study
Official title: A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Blast Phase Refractory to Imatinib Mesylate (STI 571)
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- decitabine (5-aza-2'deoxycytidine)
- Keywords
- Chronic myelogenous leukemia, CML, CML-BP, Blast phase, Decitabine, 5-aza-2'deoxycytidine, Methylation, STI 571, Imatinib mesylate, Gleevec, BCR/ABL
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabine (5-aza-2'deoxycytidine)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2002 (estimated)
- Study startJul 2002
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042003
- Sponsor's protocol ID
- DAC-012
- Other IDs
- DACO-012
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2002
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Blast Phase Refractory to Imatinib Mesylate (STI 571)
- ClinicalTrials.gov ID
- NCT00042003
- Acronym / sponsor ID
- DAC-012
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Chronic myelogenous leukemia, CML, CML-BP, Blast phase, Decitabine, 5-aza-2'deoxycytidine, Methylation, STI 571
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Study start
- Jul 2002
- Primary completion
- Dec 2004 (actual)
- First posted
- 23 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of CML blast phase
- Ph chromosome-positive
- Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
- Patients must have recovered from the side effects of previous CML therapy for blast phase with the exception of hydroxyurea
- Age >/= 2 years
Key exclusion criteria (9 listed)
- Leukemic involvement of the central nervous system
- Active malignancy other than CML or non-melanoma cancer of the skin
- Previous treatment for CML with another investigational agent within 28 days of study entry
- At study entry, patients who were treated with: imatinib mesylate within the past 48 hours, interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
- Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
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 |
|---|---|---|
| decitabine (5-aza-2'deoxycytidine) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing decitabine (5-aza-2'deoxycytidine) in people with Chronic Myelogenous Leukemia, run by Astex Pharmaceuticals, Inc. at 8 sites in 2 countries.
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 9 inclusion and 9 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 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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.
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 2 Aug 2024.