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

Study Overview
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Brief Summary
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Time-to-Progression (TTP)

Detailed Description
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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.

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

Conditions
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Leukemia, Relapsed Adult Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenalidomide 50 mg/day x 28 days<br>Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions. | Drug: Lenalidomide<br>* 50 mg; po<br>* Other names: Revlimid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-Progression (TTP) |  | 12 weeks |