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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2013 |
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Main ID: |
NCT00546897 |
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Date of registration:
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17/10/2007 |
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Primary sponsor: |
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Public title:
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Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities
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Scientific title:
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Phase II Trial of Lenalidomide in Older Patients (>/= 60 Years) With Untreated Acute Myeloid Leukemia Without Chromosome 5q Abnormalities |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00546897 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ravi Vij, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University in St. Louis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- AML, de novo, secondary to prior therapy, or transformed from MDS, as defined by the
International Working Group (except acute promyelocytic leukemia (AML M3). Patients
must not have abnormalities of chromosome 5q as assessed by routine cytogenetics or
FISH. Diagnosis of AML by WHO criteria (=20% blasts) is determined by CBC, bone
marrow assessment, and immunophenotypic analysis performed within 2 weeks of study
enrollment.
- Intermediate or poor-risk cytogenetics as defined by SWOG criteria
- Age = 60 years at the time of signing the informed consent form.
- Understand and voluntarily sign an informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- No previous treatment for AML, however hydroxyurea, steroids, and leukopheresis are
allowed
- ECOG performance status of = 2 at study entry.
- Life expectancy > 2 months
- Adequate organ function as defined by:
- Serum creatinine = 1.5X institution upper limit of normal (ULN)
- Total bilirubin = 2.0 mg/dL
- AST (SGOT) and ALT (SGPT) = 5 x ULN
- Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
and again within 24 hours of starting lenalidomide and must either commit to
continued abstinence from heterosexual intercourse or begin TWO acceptable methods of
birth control, one highly effective method and one additional effective method AT THE
SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also
agree to ongoing pregnancy testing. Men must agree to use a latex condom during
sexual contact with a FCBP even if they have had a successful vasectomy. All
patients must be counseled at a minimum of every 28 days about pregnancy precautions
and risks of fetal exposure.
- Disease free of prior malignancies for = 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast.
Exclusion Criteria:
- Received prior treatment for AML
- Favorable risk cytogenetic abnormalities as defined by SWOG criteria
(http://www.bloodjournal.org/cgi/content/abstract/96/13/4075) that include:
inv(16)/t(16;16)/del(16q), t(15;17) with/without secondary aberrations, t(8;21)
lacking del(9q) or complex karyotype (16). Prior to enrollment, FISH, molecular
studies or routine cytogenetics must be completed to rule out these cytogenetic
abnormalities.
- Known CNS leukemia
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 30 days of enrollment.
- Known hypersensitivity to thalidomide.
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Leukemia, Myeloid, Acute
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Intervention(s)
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Drug: Lenalidomide
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Primary Outcome(s)
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To assess the morphologic complete remission rate (CR) of lenalidomide therapy in this patient population
[Time Frame: 30 days, 60 days, and after 2 cycles of low dose therapy]
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Secondary Outcome(s)
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To assess overall survival (OS) and event free survival (EFS)
[Time Frame: Minimum of 1 year]
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To assess relapse free survival (RFS) and duration of CR for complete responders
[Time Frame: Minimum of 1 year]
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To assess the response rate (RR), morphologic leukemia-free state, morphologic complete remission rate (CRm), cytogenetics CR (CRc) rate, CR with incomplete blood counts (CRi) rate, and partial remission (PR) rate
[Time Frame: 30 days, 60 days, and after 2 cycles of low dose therapy]
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To assess the safety and tolerability of lenalidomide therapy in this patient population
[Time Frame: 4 weeks after last dose of study drug]
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To assess time to progression (TTP)
[Time Frame: 30 days, 60 days, and after 2 cycles of low dose therapy]
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To evaluate changes in NK cell number and function, gene expression profiles of bone marrow and peripheral blood, and plasma proteins via proteomics, before, during, and after lenalidomide therapy (correlative studies)
[Time Frame: C1D15, Day 30, Day 60, Cycle 2, 4, 6, and 12 of low dose lenalidomide, and off study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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