Evaluation of the Immune Restoration Potential Of Lenalidomide

NCT02371577 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 141671
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is phase 2 study of the immunomodulatory drug, lenalidomide, to evaluate potential beneficial effects on the immune system of patients with chronic lymphocytic leukemia (CLL) and CLL-associated immunodeficiency. 17 patients will be enrolled with CLL, small lymphocytic lymphoma (SLL), or monoclonal B-cell lymphocytosis (MBL), and measurable immune compromise, but not an iwCLL indication for CLL therapy (ie non-progressive disease).

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

Revlimid

Outcome Measures

Primary Outcomes (1)

• Immunoglobulin G level

  IgG levels during and at the completion of 6 months of lenalidomide

  2 years

Secondary Outcomes (2)

• Treatment-emergent adverse events, including infections

  2 years

• Progression free survival rate at 6 months, determined by International Working Group in CLL (iwCLL) criteria.

  2 years

Study Arms (1)

Lenalidomide

EXPERIMENTAL

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.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

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.

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• 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:
• Platelet count ≥ 50,000/µL; AND 8.2. Hemoglobin ≥ 8.0 g/dL 8.3. Absolute neutrophil count \> 1000 /uL
• Adequate renal function:
• Serum creatinine \<1.5 times upper limit of normal; OR 9.2. Calculated Creatinine clearance (CrCl) ≥ 50 mL/min
• Adequate hepatic function:
• 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®.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Celgene Corporation: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Michael Choi, MD

  UC San Diego Moores Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (1)