Status:
TERMINATED
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia
Relapsed Adult Acute Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01401322
Start Date
January 1 2011
End Date
May 1 2012
Last Update
November 28 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305