Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)

NCT00860457 | Completed Phase 2 Results DMC

• 1 other identifier: RV-CLL-PI-089
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease. Current therapy for this disease includes the use of combination chemotherapy regimens containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this research because we are attempting to improve the response, or outcome, of Fludarabine and Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. This research is being done because we are attempting to find a better treatment for chronic lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of Fludarabine and Rituximab. The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and Rituximab alone.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be \< 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.

  3 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Fludarabine/Rituximab followed by Lenalidomide

Drug: Rituximab; Drug: Fludarabine; Drug: Lenalidomide

Interventions

Rituximab DRUG

375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles

Also known as: Rituxan

Chemotherapy

Fludarabine DRUG

25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles

Also known as: Fludara

Chemotherapy

Lenalidomide DRUG

5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles

Also known as: Revlimid

Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign informed consent form
• No prior therapy for CLL
• Able to adhere to study visit schedule and other protocol requirements
• CLL with any Rai Stage requiring therapy
• ECOG performance status \</= 2
• Absolute neutrophil count \>/= 1.0
• Platelet count \>/= 75
• Serum creatinine \</= 1.5
• Total bilirubin \</= 1.5
• AST and ALT \</= 2 x ULN
• Females of childbearing potential must have negative pregnancy test
• Disease free of prior malignancies for \>/= 5 years
• Able to take aspirin daily as prophylactic anticoagulation

You may not qualify if:

• Any serious medical condition, lab abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Pregnant or lactating females
• Any condition, including the presence of lab abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• Use of any other experimental drug or therapy within 28 days of baseline
• Concurrent use of other anti-cancer agents or treatments
• Known positive for HIV or infectious active hepatitis, type A, B
• Known hypersensitivity to nucleoside analogue or rituximab
• Previous treatment for CLL prior to enrolling in study
• Known hypersensitivity to thalidomide
• The development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
• Any prior use of lenalidomide
• Active hemolysis

Sponsors & Collaborators

• Georgetown University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

Rituximab; fludarabine; fludarabine phosphate; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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: Dr. Bruce D. Cheson
• Organization: Lombardi Comprehensive Cancer Center, Georgetown University Hospital

bdc4@georgetown.edu

202-444-7932

Study Officials

• Bruce D Cheson, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 12, 2009
• Study Start: February 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: February 1, 2012
• Last Updated: November 21, 2018
• Results First Posted: August 18, 2014

Record last verified: 2014-08

Locations

US (1)