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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401322
Recruitment Status : Terminated (low accrual)
First Posted : July 25, 2011
Results First Posted : November 10, 2014
Last Update Posted : November 28, 2016
Celgene Corporation
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University

July 20, 2011
July 25, 2011
October 27, 2014
November 10, 2014
November 28, 2016
January 2011
January 2012   (Final data collection date for primary outcome measure)
Time-to-Progression (TTP) [ Time Frame: 12 weeks ]
  • Progression-Free Survival (PFS) [ Time Frame: 3 years ]
  • Overall Survival (OS) [ Time Frame: 3 years ]
Complete list of historical versions of study NCT01401322 on Archive Site
Not Provided
Tumor Response (TR) [ Time Frame: 3 years ]
Not Provided
Not Provided
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Time-to-Progression (TTP)
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Relapsed Adult Acute Lymphocytic Leukemia
Drug: Lenalidomide
50 mg; po
Other Name: Revlimid
Experimental: Lenalidomide 50 mg/day x 28 days
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: Drug: Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
SU-01142011-7364 ( Other Identifier: Stanford University )
RV_ALL_PI_0616 ( Other Identifier: Celgene Corporation )
HEMALL0006 ( Other Identifier: OnCore )
Not Provided
Not Provided
Bruno C. Medeiros, Stanford University
Stanford University
Celgene Corporation
Principal Investigator: Bruno Carneiro de Medeiros Stanford University
Stanford University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP