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

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Bruno C. Medeiros, Stanford University
ClinicalTrials.gov Identifier:
NCT01401322
First received: July 20, 2011
Last updated: November 3, 2014
Last verified: November 2014

July 20, 2011
November 3, 2014
January 2011
January 2012   (final data collection date for primary outcome measure)
Time-to-Progression (TTP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01401322 on ClinicalTrials.gov Archive Site
Not Provided
Tumor Response (TR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01401322
IRB-19607, SU-01142011-7364, RV_ALL_PI_0616, HEMALL0006
Yes
Bruno C. Medeiros, Stanford University
Stanford University
Celgene Corporation
Principal Investigator: Bruno Carneiro de Medeiros Stanford University
Stanford University
November 2014

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