Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia

Trial ID or NCT#

NCT01401322

Status

not recruiting iconNOT RECRUITING

Purpose

Time-to-Progression (TTP)

Official Title

Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
View All Criteria
Show Less

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov