Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Condition: Leukemia; Relapsed Adult Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Lenalidomide
Intervention description: 50 mg; po
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Time-to-Progression (TTP)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory acute lymphoblastic leukemia (ALL) with > 10% bone marrow or
             peripheral blood blasts per WHO-criteria. Refractory define as failure to achieve CR
             after prior therapy.

          -  Previously untreated patients > 60, if not candidates for standard induction

          -  Age ≥ 18

          -  Not a candidate for curative treatment regimens

          -  Unwilling or unable to receive conventional chemotherapy

          -  ECOG performance status ≤ 2

          -  Life expectancy > 2 months

          -  Registered to in RevAssist restricted distribution program, and willing and able to
             comply with the program requirement

          -  Females of childbearing potential (FCBP):

               -  Must have a negative serum or urine pregnancy test (sensitivity of at least 50
                  mIU/mL) 10 to 14 days prior to study enrollment and within 24 hours prior to
                  prescribing lenalidomide

               -  Must either commit to continued abstinence from heterosexual intercourse or begin
                  two acceptable methods of birth control

               -  Agree to ongoing pregnancy testing

          -  Men must agree to use a latex condom during sexual contact with a FCBP

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Willing and able to understand and voluntarily sign a written informed consent

        Exclusion Criteria:

          -  Prior therapy with lenalidomide

          -  History of intolerance to thalidomide including development of erythema nodosum while
             taking thalidomide or similar drugs

          -  Advanced malignant hepatic tumors.

          -  Concomitant treatment with other anti-neoplastic agents (exception hydroxyurea)

          -  Anti-neoplastic treatment less than 4 weeks prior to enrollment (exception
             hydroxyurea)

          -  Use of any other experimental drug or therapy within 14 days of baseline

          -  Inability to swallow or absorb drug

          -  Active opportunistic infection or treatment for opportunistic infection within 4 weeks
             of first dose of study drug

          -  New York Heart Association Class III or IV heart failure

          -  Unstable angina pectoris

          -  Cardiac arrhythmias with rapid ventricular response (heart rate > 100 beats/minute)

          -  Uncontrolled psychiatric illness that would limit compliance with requirements

          -  Known HIV infection

          -  Known active hepatitis B virus (HBV) (exception seropositivity due to HBV vaccine not
             considered active HBV)

          -  Known hepatitis C virus (HCV) infection

          -  Pregnant

          -  Lactating females must agree not to breastfeed while taking lenalidomide

          -  Other medical or psychiatric illness or organ dysfunction or laboratory abnormality
             which in the opinion of the investigator would compromise the patient's safety or
             interfere with data interpretation

          -  Creatinine ≥ 1.5 mg/dL

          -  Creatinine clearance ≤ 60 mL/min.

          -  Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (exception
             documented Gilbert's syndrome)

          -  AST and ALT > 3 x institutional ULN