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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

Brief Summary:
Time-to-Progression (TTP)

Condition or disease Intervention/treatment Phase
Leukemia Relapsed Adult Acute Lymphocytic Leukemia Drug: Lenalidomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
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.
Drug: Lenalidomide
50 mg; po
Other Name: Revlimid

Primary Outcome Measures :
  1. Time-to-Progression (TTP) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01401322

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
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Principal Investigator: Bruno Carneiro de Medeiros Stanford University
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Responsible Party: Bruno C. Medeiros, Assistant Professor of Medicine (Hematology), Stanford University Identifier: NCT01401322    
Other Study ID Numbers: IRB-19607
SU-01142011-7364 ( Other Identifier: Stanford University )
RV_ALL_PI_0616 ( Other Identifier: Celgene Corporation )
HEMALL0006 ( Other Identifier: OnCore )
First Posted: July 25, 2011    Key Record Dates
Results First Posted: November 10, 2014
Last Update Posted: November 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents