Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia

Stopped early · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving rituximab together with alemtuzumab may kill more cancer cells. PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.

Key facts

Study ID

NCT01013961

Run by

ECOG-ACRIN Cancer Research Group

People needed

31

Starts

2011-04-27

Expected to finish

2015-04-14

Last updated by the study team

2023-06-28

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:
• Minimum threshold peripheral lymphocyte count of 5 x 10\^9/L (CLL variant) OR palpable adenopathy > 1 cm or palpable splenomegaly 9small lymphocytic lymphoma [SLL] variant)
• Immunophenotypic demonstrations of a population of B-lymphocytes (as defined by CD19+) that are monoclonal (by light-chain exclusion) AND have ≥ 3 of the following characteristics:
• CD5+
• CD23+
• Dim surface light chain expression
• Dim surface CD20 expression
• FISH analysis is negative for immunoglobulin heavy chain/cyclin D1 gene (IGH/CCND1) and/or immunostaining is negative for cyclin D1 expression (to exclude mantle cell lymphoma)
• Progressive, symptomatic CLL, defined by at least one of the following:
• Weight loss > 10% within the past 6 months attributable to progressive CLL (grade 2 or higher)
• Extreme fatigue attributable to progressive CLL (grade 3 or higher)
• Fevers > 100.5° F for 2 weeks without evidence of infection (grade 1 or higher)
• Night sweats without evidence of infection (drenching)
• Evidence of progressive bone marrow failure with hemoglobin < 11 g/dL or platelet count < 100 x 10\^9/L
• Rapidly progressive lymphadenopathy for which the largest node is ≤ 5 cm in any dimension
• Largest lymph nodes involved in the neck, axilla, and groin need to be measured and followed for response

You may not qualify if…

• Prior treatment for CLL
• Massive splenomegaly > 6 cm below left costal margin, at rest, on clinical examination
• Lymphadenopathy > 5 cm in any diameter
• New York Heart Association class III or IV heart disease
• Recent myocardial infarction (within the past month)
• Uncontrolled infection
• Infection with the human immunodeficiency virus (HIV/AIDS)
• Serological evidence of active hepatitis B infection (HBsAg or HBeAg positive)
• Positive hepatitis C serology
• Evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
• Other active primary malignancy requiring treatment or that limits survival to ≤ 2 years, except for in situ carcinoma of the cervix or breast or non-metastatic basal cell or squamous cell carcinoma of the skin
• Major surgery within 4 weeks prior to pre-registration
• Concomitant use of continuous systemic corticosteroids
• Prior corticosteroids are allowed but not at time of pre-registration to the study

Where it is running

• Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Ella Milbank Foshay Cancer Center at Jupiter Medical Center — Jupiter, Florida, United States
• CCOP - Mount Sinai Medical Center — Miami Beach, Florida, United States
• Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler — Savannah, Georgia, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• Illinois CancerCare - Bloomington — Bloomington, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Illinois CancerCare - Canton — Canton, Illinois, United States
• Illinois CancerCare - Carthage — Carthage, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• University of Chicago Cancer Research Center — Chicago, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Illinois CancerCare - Eureka — Eureka, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Illinois CancerCare - Havana — Havana, Illinois, United States
• Illinois CancerCare - Kewanee Clinic — Kewanee, Illinois, United States
• Illinois CancerCare - Macomb — Macomb, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• Illinois CancerCare - Monmouth — Monmouth, Illinois, United States
• OSF Holy Family Medical Center — Monmouth, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Illinois CancerCare - Community Cancer Center — Normal, Illinois, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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