Acute Myelogenous LeukemiaPhase 1NCT00274248
MLN518 in Combination With Standard Induction Chemo. for Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia
A Phase 1 study testing MLN518 in people with Acute Myelogenous Leukemia, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a phase 1, open-label, multicenter study investigating the use of MLN518 in combination with standard chemotherapy to patients with newly diagnosed AML. Two dose levels of MLN518-200 mg and 400 mg given orally twice a day are planned for sequential evaluation in separate groups of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- MLN518
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2007
- Phase
- Phase 1
- 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
Who may be able to join
- Male or female patients, at least 18 years of age, with newly diagnosed (previously untreated) AML, regardless of the mutational status of FLT3 in their leukemic blasts.
- Unequivocal histologic diagnosis of AML (based on the World Health Organization [WHO] and/or FAB classifications), excluding acute promyelocytic leukemia. AML patients with a history of antecedent myelodysplasia (MDS) are eligible for treatment in this trial but must not have had prior cytotoxic therapy for MDS.
- No prior anti-neoplastic therapy for leukemia or MDS with the following exceptions:
- emergency leukapheresis;
- emergency treatment for hyperleukocytosis with hydroxyurea;
- growth factor/cytokine support.
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- Eastern Cooperative Oncology Group performance status of 0 to 3
- Pretreatment laboratory test values within the following limits no more than 7 days before enrollment:
- total bilirubin equal or less then 1.5 x the upper limit of normal;
- Alanine aminotransferase and aspartate aminotransferase equal or less then 2.5 x the ULN;
- serum creatinine equal or less then 2.0 mg/dL.
- Male patients must use an appropriate method of barrier contraception during the study.
- Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control (ie, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence) for the duration of the study.
- Ability to voluntarily provide written informed consent before the performance of any study related procedure not part of normal medical care.
Who cannot join
- An active malignancy other than AML (with the exception of basal and/or squamous cell skin cancers and curatively treated carcinoma of the cervix) at the time of study entry.
- Suspected or confirmed diagnosis of acute promyelocytic leukemia [t (15;17)(q22;q12)].
- Documented or suspected central nervous system (CNS) involvement with leukemia.
- Ongoing vomiting.
- Nausea of intensity greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.
- Known gastrointestinal disease that could interfere with the oral absorption of MLN518.
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- Severe CNS, pulmonary, renal, or hepatic disease not related to the patient's AML.
- A left ventricular ejection fraction < 40%.
- Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 3), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- QTc > 500 msec.
- Known or suspected infection with human immunodeficiency virus (HIV).
- Known active infection with hepatitis B or hepatitis C.
- Known or suspected primary muscular or neuromuscular disease (eg, muscular dystrophy, myasthenia gravis).
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Inability to provide written informed consent to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Dana Farber Cancer Institute
Boston, Massachusetts, 02134
About this study
Official title: A Phase 1 Study of MLN518 Given in Combination With Standard Induction Chemotherapy for the Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia
This is a phase 1, open-label, multicenter study investigating the use of MLN518 in combination with standard chemotherapy to patients with newly diagnosed AML. Two dose levels of MLN518-200 mg and 400 mg given orally twice a day are planned for sequential evaluation in separate groups of patients. Patients assigned to the 400 mg dose level given orally twice a day of MLN518, will potentially have their dose of MLN518 adjusted on the basis of MLN518 plasma concentrations measured during the first 3 days of induction therapy. All patients will receive initial induction chemotherapy with cytarabine, 200 mg/m2/day by CIVI on Days 1 through 7, and with daunorubicin, 60 mg/m2/day by intravenous (IV) push (IV infusion if borderline cardiac function is detected) on Days 1 through 3 ("7+3"). An abbreviated cytarabine and daunorubicin regimen ("5+2") will also be used when the initial remission induction therapy fails to clear the bone marrow of blast cells (as typically detected on the Day 15 bone marrow) and a second attempt at remission induction is indicated. Patients who achieve a complete remission (CR) will receive consolidation therapy with HiDAC (standard or modified) in combination with continued MLN518 treatment. Patients remaining in continuous CR after completion of their last cycle of consolidation therapy will be permitted to continue treatment with single-agent MLN518 for 6 months thereafter.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- MLN518
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN518Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startMar 2005
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274248
- Sponsor's protocol ID
- C03001
- Status last verified
- Feb 2008
- First submitted
- 9 Jan 2006
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of MLN518 Given in Combination With Standard Induction Chemotherapy for the Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00274248
- Acronym / sponsor ID
- C03001
- Conditions
- Acute Myelogenous Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2007 (actual)
- First posted
- 10 Jan 2006 (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.
This is a phase 1, open-label, multicenter study investigating the use of MLN518 in combination with standard chemotherapy to patients with newly diagnosed AML. Two dose levels of MLN518-200 mg and 400 mg given orally twice a day are planned for sequential evaluation in separate groups of patients. Patients assigned to the 400 mg dose level given orally twice a day of MLN518, will potentially have their dose of MLN518 adjusted on the basis of MLN518 plasma concentrations measured during the first 3 days of induction therapy. All patients will receive initial induction chemotherapy with cytarabine, 200 mg/m2/day by CIVI on Days 1 through 7, and with daunorubicin, 60 mg/m2/day by intravenous (IV) push (IV infusion if borderline cardiac function is detected) on Days 1 through 3 ("7+3"). An abbreviated cytarabine and daunorubicin regimen ("5+2") will also be used when the initial remission induction therapy fails to clear the bone marrow of blast cells (as typically detected on the Day 15 bone marrow) and a second attempt at remission induction is indicated. Patients who achieve a complete remission (CR) will receive consolidation therapy with HiDAC (standard or modified) in combination with continued MLN518 treatment. Patients remaining in continuous CR after completion of their last cycle of consolidation therapy will be permitted to continue treatment with single-agent MLN518 for 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patients, at least 18 years of age, with newly diagnosed (previously untreated) AML, regardless of the mutational status of FLT3 in their leukemic blasts.
- Unequivocal histologic diagnosis of AML (based on the World Health Organization [WHO] and/or FAB classifications), excluding acute promyelocytic leukemia. AML patients with a history of antecedent myelodysplasia (MDS) are eligible for treatment in this trial but must not have had prior cytotoxic therapy for MDS.
- No prior anti-neoplastic therapy for leukemia or MDS with the following exceptions:
- Eastern Cooperative Oncology Group performance status of 0 to 3
- Pretreatment laboratory test values within the following limits no more than 7 days before enrollment:
Key exclusion criteria (15 listed)
- An active malignancy other than AML (with the exception of basal and/or squamous cell skin cancers and curatively treated carcinoma of the cervix) at the time of study entry.
- Suspected or confirmed diagnosis of acute promyelocytic leukemia [t (15;17)(q22;q12)].
- Documented or suspected central nervous system (CNS) involvement with leukemia.
- Ongoing vomiting.
- Nausea of intensity greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.
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 |
|---|---|---|
| MLN518 | 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 11 Feb 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MLN518 in people with Acute Myelogenous Leukemia, run by Millennium Pharmaceuticals, Inc. 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 14 inclusion and 15 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 11 Feb 2008. 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 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.
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 11 Feb 2008.