low accrual

Time-to-Progression (TTP)

Determine the time-to-progression (TTP) for subjects with relapsed/refractory acute lymphoblastic leukemia (ALL) receiving single agent lenalidomide 50 mg/day for 28 days/cycle.

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

Relapsed or refractory ALL (at least 1 failed prior treatment regimen)

12 weeks