Print Friendly Page

Protocol No. HO11414

Principal Investigator Chang, Julie

Phase II

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab + Lenalidomide in Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Objective The purpose of this research is to evaluate a new combination of drugs for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an oral medication).

Treatment While bendamustine and rituximab are FDA approved for your type of cancer, lenalidomide is not FDA approved for your type of cancer, and is considered experimental. Linalidomide is a drug that alters the body's immune system (i.e., the part of your body that protects you from infection) and it may also interfere with the development of tiny blood vessels that help support tumor growth. This drug is considered experimental for treatment of your type of disease.

Description During the first 6 months of the study, you will be receiving bendamustine and rituximab treatment. After that, you will be receiving the lenalidomide capsule daily for 24 months, and receive treatments with rituximab every other month for 24 months. Click here for more info

Key Eligibility
  • Histologically confirmed CLL/SL
  • No prior cytotoxic chemotherapy for their disease; prior therapy with single-agent rituximab is permitted
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation
  • Concurrent use of other anti-cancer agents or treatments is not allowed
  • Not eligible if positive for HIV or infectious hepatitis (type B or C)
  • Not eligible if positive for chronic hepatitis B or hepatitis C infection

Applicable Disease Sites Lymphoma

Therapies Involved Cytotoxic Chemotherapy; Immunotherapy; Other

Drugs Involved CC-5013 (Lenalidomide); Lenalidomide; Revlimid (Lenalidomide); SDX-105 (bendamustine); Treanda (bendamustine); bendamustine; chimeric anti-CD20 monoclonal antibody (rituximab); idec-c2B8 (rituximab); rituxan (rituximab); rituximab

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park