Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities

Completed · Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

This study is designed to test the safety and efficacy of lenalidomide in older patients (age \> 60 years) with untreated acute myeloid leukemia without chromosomal abnormalities involving 5q.

Key facts

Study ID

NCT00546897

Run by

Washington University School of Medicine

People needed

48

Starts

2007-02-01

Expected to finish

2012-03-01

Last updated by the study team

2014-09-29

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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