Revlimid® as Consolidation Treatment Chronic Lymphocytic Leukemia

NCT01600053 | Terminated Phase 2 Results DMC

• 1 other identifier: 101955
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether on course (6 cycles) of consolidation therapy with Revlimid can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL) in the bone marrow.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic; Lymphocytic; Leukemia

Outcome Measures

Primary Outcomes (1)

• Eradication of Residual Disease From the Marrow

  From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.

Secondary Outcomes (1)

• Recording of the Occurrence of Adverse Events

  From date of first dose until the date of first documented progression or date of death from any cause, whichever came first

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.

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:

• Diagnosis of chronic lymphocytic leukemia:
• Previously treated patients of any age with a diagnosis of CLL with documented residual disease following therapy, but not meeting an indication for treatment based on current guidelines
• At least 2 months following previous CLL directed therapy
• ECOG performance status of less than or equal to 2 at study entry
• Laboratory test results within these ranges:
• Platelet count greater than or equal to 50 x 109/L
• CrCl \>.60 ml/min
• Total bilirubin less than or equal to 1.5 mg/dL
• AST (SGOT) and ALT (SGPT) less than or equal to 2 x ULN
• Females of childbearing must adhere to strict guidelines and have negative pregnancy test prior to enrollment
• Understand and voluntarily sign an informed consent form.
• Age greater than or equal to 18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Disease free of prior malignancies for greater than or equal to 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ" of the cervix or breast.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

You may not qualify if:

• Known Hepatitis B Ag positive, Hepatitis C positive patients.
• Known HIV positive patients.
• Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP)
• Patients with active fungal, bacterial, and/or viral infection
• Patients with known hypersensitivity to Revlimid or thalidomide
• Concurrent use of other anti-cancer agents or treatments
• Patients with history of deep venous thrombus or pulmonary embolism
• Patients who are at increased risk of thrombosis during treatment with Revlimid including those taking concurrent erythropoietin, darbepoetin or high-dose corticosteroids
• Inability to provide informed consent.
• Concurrent malignancy (excluding basal and squamous cell skin cancers).
• Pregnant or breast-feeding females. (Lactating females must agree not to breast feed while taking Revlimid).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral arterial disease or of recent MI whether or not treated with anti-platelet drug.

Sponsors & Collaborators

• Thomas Kipps: lead
• Celgene Corporation: collaborator

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093-0698, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Bronchiolitis Obliterans Syndrome; Leukemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; 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; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

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

Results Point of Contact

• Title: Thomas Kipps, MD
• Organization: University of California, San Diego

tkipps@ucsd.edu

(858) 534-5400

Study Officials

• Thomas J. Kipps, M.D., Ph.D.

  University of California Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interim Director

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 16, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 15, 2016
• Results First Posted: December 15, 2016

Record last verified: 2016-10

Locations

US (1)