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Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)

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: NCT01924169
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 16, 2013
Results First Posted : March 27, 2018
Last Update Posted : September 20, 2018
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if lenalidomide can increase the level of immunoglobulins (parts of the blood that may help to improve the immune system's function) and/or will improve the protective effect of the flu and pneumonia vaccines in patients with CLL.

Condition or disease Intervention/treatment Phase
Hematologic Disorder Drug: Lenalidomide Biological: Influenza Vaccine Biological: Pneumovax Vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study of Immune-adjuvant Effect of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Hypogammaglobulinemia and Impaired Response to Vaccinations - RV-CL-CLL-PI-002544
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017

Arm Intervention/treatment
Experimental: Lenalidomide
Lenalidomide administered at the dose of 5 mg/day on Monday, Wednesday and Friday for 3 months. If Immunoglobulin G (IgG) levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years. Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21.
Drug: Lenalidomide

5 mg/day by mouth on Monday, Wednesday and Friday for 3 months. Process repeated for up to 2 years.

If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day by mouth for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

Other Names:
  • CC-5013
  • Revlimid

Biological: Influenza Vaccine
Administered as injection yearly, during the fall/winter season.
Other Name: TIV

Biological: Pneumovax Vaccine
Administered by injection once between month 6 and month 21. Patients, who have received the Pneumovax vaccine within last 5 years, will not receive Pneumovax vaccination.
Other Name: Pneumonia vaccine

Primary Outcome Measures :
  1. Number of Participants With IgG Response [ Time Frame: 6 months ]
    IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.

Secondary Outcome Measures :
  1. Seroconversion Response [ Time Frame: 4 weeks after flu vaccine administered ]
    Study considered positive in regard to the secondary endpoints if seroconversion is observed in 60% or more of the subjects for at least one of the vaccinations given.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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:

  1. Chronic lymphocytic leukemia (CLL) patients with IgG less than 500 mg/dl with/without symptoms who are either untreated or previously treated, regardless of response, at least 6 months from prior therapy (including mAb)..
  2. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2.
  3. Adequate renal functions as indicated by serum creatinine equal to or less than 2 mg/dl.
  4. Adequate hepatic function indicated as total bilirubin equal to or less than 2 mg/dl and alanine aminotransferase (ALT) equal to or less than two times the upper limit of normal.
  5. Disease free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
  6. Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has not had menses at any time in preceding 24 consecutive months)>
  7. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide.
  8. FCBP must also agree to ongoing pregnancy testing (weekly for the first four weeks and then every 28 days while on therapy and at discontinuation of treatment).
  9. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  10. Patients must be 18 years of age or older.
  11. All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
  12. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Exclusion Criteria:

  1. Known sensitivity to lenalidomide or other thalidomide derivatives.
  2. History of Guillain-Barre within 6 weeks of previous influenza vaccination.
  3. Patient on steroid therapy.
  4. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood) or Richter's transformation.
  5. Known positivity for HIV or active hepatitis B or C.
  6. Pregnant or breast feeding females.
  7. History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
  8. Any serious medical condition, laboratory abnormality or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
  9. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE), in six months prior to enrollment are not eligible for this study.
  10. Subjects who have currently active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome).
  11. Patients with severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine or to a vaccine component, including egg protein.
  12. Moderate or severe acute illness with or without fever.
  13. Use of any other experimental drug or therapy within 28 days of baseline.
  14. Concurrent use of other anti-cancer agents or treatments.

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): NCT01924169

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
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Principal Investigator: Alessandra Ferrajoli, MD,BS M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol  [PDF] July 3, 2013
Statistical Analysis Plan  [PDF] July 3, 2013

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01924169     History of Changes
Other Study ID Numbers: 2013-0371
NCI-2014-01058 ( Registry Identifier: NCI CTRP )
First Posted: August 16, 2013    Key Record Dates
Results First Posted: March 27, 2018
Last Update Posted: September 20, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Hematologic Disorder
Impaired Response to Vaccinations
Immune system's function
Flu vaccine
Pneumonia vaccine
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Hematologic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents