NCT01401322TerminatedPhase 2
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Time-to-Progression (TTP)
Study Overview
Brief Summary
Time-to-Progression (TTP)
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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
Arms & Interventions
Lenalidomide 50 mg/day x 28 days
Experimental
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.
Intervention: Lenalidomide (Drug)
Outcomes
Primary Outcomes
Time-to-Progression (TTP)
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Bruno C. Medeiros
Assistant Professor of Medicine (Hematology)
Stanford University
Study Sites (1)
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