- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371577
Evaluation of the Immune Restoration Potential Of Lenalidomide (Revlimid)
A Phase 2 Clinical Trial To Evaluate The Immune Restoration Potential Of Lenalidomide For Patients With CLL-Associated Immunodeficiency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Main Inclusion Criteria:
- Clinical and phenotypic verification of B cell CLL/ SLL/ or MBL and measurable disease.
- Subjects must have total serum IgG < 500 mg/dL
- Disease Status/ Prior Therapy: There is not any requirement nor restriction for prior therapy.
- Recovered from the toxic effects of prior therapy to their clinical baseline.
- Both men and women of all races and ethnic groups are eligible for this trial.
- Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 8 weeks after the final dose of lenalidomide.
- ECOG performance status of 0-2.
Adequate hematologic function:
8.1. Platelet count ≥ 50,000/µL; AND 8.2. Hemoglobin ≥ 8.0 g/dL 8.3. Absolute neutrophil count > 1000 /uL
Adequate renal function:
9.1. Serum creatinine <1.5 times upper limit of normal; OR 9.2. Calculated Creatinine clearance (CrCl) ≥ 50 mL/min
Adequate hepatic function:
12.1. Total bilirubin ≤ 2.5 times upper limit of normal; AND 12.2. ALT ≤ 2.5 times upper limit of normal.
- Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or equivalent anticoagulation as prophylactic medication.
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of REMS®.
- Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to starting Revlimid® and must either commit to continued abstinence 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 Revlimid®. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
Exclusion Criteria:
- Progressive CLL requiring therapy based on 2008 international working group guidelines (iwCLL 2008, Hallek et al, Blood 2008).
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- Known hypersensitivity to thalidomide or lenalidomide.
- Prior lenalidomide-associated deep vein thrombosis
- Deep vein thrombosis or superficial thrombophlebitis of any cause on current anticoagulation therapy at the time of screening.
- Patients who are currently receiving another investigational agent are excluded.
- Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), radiation therapy, tyrosine kinase inhibitor therapy, or participation in any investigational drug treatment within 4 weeks of initiation of lenalidomide or at any time during the study.
- Patients who have had prior (within 8 weeks of initiation of lenalidomide) or concurrent antibody therapy directed against CLL.
- Current infection requiring parenteral antibiotics.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV); or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) based on detectable viral load. Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Active malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ).
- Known history of IgA or IgG monoclonal gammopathy of undetermined significance (MGUS)
- Known central nervous system (CNS) involvement by malignancy.
- Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lenalidomide
Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle.
The typical starting dose is 2.5mg PO daily.
At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, in the absence of grade 2 or higher adverse events.
|
Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle.
The typical starting dose is 2.5mg PO daily.
At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, in the absence of grade 2 or higher adverse events Duration of lenalidomide on the clinical trial is for up to 6 cycles, each of 28 day duration.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunoglobulin G level
Time Frame: 2 years
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IgG levels during and at the completion of 6 months of lenalidomide
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment-emergent adverse events, including infections
Time Frame: 2 years
|
2 years
|
Progression free survival rate at 6 months, determined by International Working Group in CLL (iwCLL) criteria.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Choi, MD, UC San Diego Moores Cancer Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Leukemia, Lymphocytic, Chronic, B-Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- 141671
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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