Gene Therapy Clinical Trials
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Time-to-Progression (TTP)
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: lenalidomide
Eligibility
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
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting