Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: Revlimid
Intervention description: 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Summary:

      The goal of this clinical research study is to find out if Revlimid can help to control the
      disease in patients with relapsed/refractory acute myelogenous leukemia (AML) or high-risk
      myelodysplastic syndrome (MDS) with abnormalities in chromosome number 5. The safety of this
      treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age >/= 18 years at the time of signing the informed consent form. (Revlimid has not
             been tested in younger patients)

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Diagnosis of relapsed/refractory AML (other than APL) or high-risk MDS (IPSS
             categories intermediate-2 and high) with chromosome 5 abnormality as a sole
             abnormality or with additional abnormalities. MDS patients with blast percentage of
             >/= 10% will be considered high-risk.

          5. All non-hematological toxicity of previous cancer therapy should have resolved to </=
             grade1 (except alopecia or other toxicities not involving major organs).

          6. Should not have received any prior treatment for AML or MDS within 2 weeks of starting
             Revlimid. Use of hydrea to control proliferative disease will be allowed prior to
             starting Revlimid and for 7 days during cycles 1 and 2 (Maximum daily dose of 7gm).

          7. Eastern Cooperative Oncology Group (ECOG) performance status of </ =2 at study entry

          8. Laboratory test results within these ranges: • Serum creatinine </= 1.5 mg/dL • Total
             bilirubin </=1.5 mg/dL • aspartate aminotransferase (AST or SGOT) and alanine
             aminotransferase (ALT or SGPT) </=2 * upper limit of normal (ULN) or </=5 * ULN if
             related to disease

          9. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 -
             14 days prior to and again within 24 hours of prescribing Revlimid (prescriptions must
             be filled within 7 days) 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 4
             weeks before she starts taking Revlimid. FCBP must also agree to ongoing pregnancy
             testing.

         10. (continued from above) Men must agree to use a latex condom during sexual contact with
             a FCBP even if they have had a successful vasectomy.

         11. All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

         12. Disease free of prior malignancies for >/ = 2 years with exception of currently
             treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the
             cervix or breast.

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking Revlimid).

          3. 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.

          4. Use of any other experimental drug or experimental therapy within 28 days of baseline.

          5. Known hypersensitivity to thalidomide.

          6. The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          7. Any prior use of Revlimid.

          8. Concurrent use of other anti-cancer agents or treatments. (Use of hydrea permitted as
             indicated in inclusion criterion 6)

          9. Known positive for HIV or infectious hepatitis type B or C.

         10. Heart rate less than or equal to 50.