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

NCT01924169 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2013-0371NCI-2014-01058
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Disorder

Keywords

Hematologic Disorder; Chronic Lymphocytic Leukemia; CLL; Hypogammaglobulinemia; Impaired Response to Vaccinations; Immunoglobulins; Immune system's function; Lenalidomide; CC-5013; Revlimid; Flu vaccine; TIV; Pneumonia vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With IgG Response

  IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.

  6 months

Secondary Outcomes (1)

• Seroconversion Response

  4 weeks after flu vaccine administered

Study Arms (1)

Lenalidomide

EXPERIMENTAL

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; Biological: Influenza Vaccine; Biological: Pneumovax Vaccine

Interventions

Lenalidomide DRUG

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.

Also known as: CC-5013, Revlimid

Lenalidomide

Influenza Vaccine BIOLOGICAL

Administered as injection yearly, during the fall/winter season.

Also known as: TIV

Lenalidomide

Pneumovax Vaccine BIOLOGICAL

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.

Also known as: Pneumonia vaccine

Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)..
• Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2.
• Adequate renal functions as indicated by serum creatinine equal to or less than 2 mg/dl.
• 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.
• 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.
• 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)\>
• 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.
• 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).
• 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.
• Patients must be 18 years of age or older.
• 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.
• 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).

You may not qualify if:

• Known sensitivity to lenalidomide or other thalidomide derivatives.
• History of Guillain-Barre within 6 weeks of previous influenza vaccination.
• Patient on steroid therapy.
• Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood) or Richter's transformation.
• Known positivity for HIV or active hepatitis B or C.
• Pregnant or breast feeding females.
• History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
• 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.
• 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.
• Subjects who have currently active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome).
• Patients with severe allergic reaction (e.g., anaphylaxis) after previous dose of any influenza vaccine or to a vaccine component, including egg protein.
• Moderate or severe acute illness with or without fever.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Concurrent use of other anti-cancer agents or treatments.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Agammaglobulinemia; Influenza, Human

Interventions

Lenalidomide; Influenza Vaccines; SARS-CoV-2 inactivated vaccines

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Protein Disorders; Immunologic Deficiency Syndromes; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Alessandra Ferrajoli, MD/Professor
• Organization: The University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Alessandra Ferrajoli, MD,BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: November 24, 2014
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: September 20, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-08

Locations

US (1)