Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

Time-to-Progression (TTP)


Condition Intervention Phase
Leukemia
Relapsed Adult Acute Lymphocytic Leukemia
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Time-to-Progression (TTP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401322

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Celgene Corporation
Investigators
Principal Investigator: Bruno Carneiro de Medeiros Stanford University
  More Information

No publications provided

Responsible Party: Bruno C. Medeiros, Assistant Professor of Medicine (Hematology), Stanford University
ClinicalTrials.gov Identifier: NCT01401322     History of Changes
Other Study ID Numbers: IRB-19607, SU-01142011-7364, RV_ALL_PI_0616, HEMALL0006
Study First Received: July 20, 2011
Results First Received: October 27, 2014
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014