Clinical trial NCT01401322: Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Official title: Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia
Relapsed Adult Acute Lymphocytic Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-07-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Time-to-Progression (TTP)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Bruno Carneiro de Medeiros
role: PRINCIPAL_INVESTIGATOR
References: