Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of lenalidomide (revlimid) in combination with fludarabine and rituximab and to determine the highest dose of lenalidomide that can safely be given in that combination. Lenalidomide is a drug that alters the immune system and may also interfere with the the development of tiny blood vessels that help support tumor growth. Lenalidomide is approved by the FDA for the treatment of two different blood cancers called myelodysplastic syndrome and multiple myeloma. Lenalidomide has also been studied in subjects with relapsed CLL. In this research study we are adding lenalidomide to a well-established initial therapy for CLL/SLL.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Celgene Corporation; Massachusetts General Hospital
• Treatments: Fludarabine; Fludarabine phosphate; Lenalidomide; Rituximab; Thalidomide; Vidarabine

Criteria

Inclusion Criteria:

• 18 years of age or older

• Diagnosed with B-CLL/SLL based on the standard histologic and immunophenotypic criteria described in the WHO classification

• No prior systemic therapy for CLL/SLL, including chemotherapy or antibody therapy

• Currently needs therapy based on 1996 NCI-WG criteria

• Measurable disease

• ECOG Performance Status of 0-2

• Laboratory test results within parameters outlined in protocol

• Able to take aspirin daily as prophylactic anticoagulation

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document

• Pregnant or breast-feeding females

• Any condition, including the presence of abnormal laboratory 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

• Known hypersensitivity to thalidomide

• Development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs

• Prior use of lenalidomide

• Concurrent use of other anti-cancer agents or treatments

• Known positive for HIV

• Chronic active Hep B patients not on prophylactic lamivudine

• Diagnosis of Mantle Cell Lymphoma