Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymph… (NCT01351896) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
United States49 participantsStarted 2011-11-02
Plain-language summary
This phase II trial studies the effect of lenalidomide and vaccine in treating patients with early-stage asymptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.
Who can participate
Age range18 Years – 79 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms
* CLL/SLL cells must demonstrate one or more of the following high-risk genomic features:
* Deletion (Del) (17p13.1) as detected by fluorescence in-situ hybridization (FISH) in \> 20% of cells
* Del(11q22.3) as detected by FISH in \> 20% of cells
* Complex karyotype (\>= 3 cytogenetic abnormalities on stimulated karyotype)
* Unmutated immunoglobulin variable heavy chain (IgVH) (\>= 98% sequence homology compared with germline sequence)
* Patients cannot meet any of the following consensus criteria for initiating treatment:
* Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
* Progressive lymphocytosis with total white blood cell (WBC) \>= 300,000/uL
* Anemia (\< 11 g/dL) or thrombocytopenia (\< 100,000/uL) due to bone marrow involvement
* Presence of unintentional weight loss \> 10% over the preceding 6 months
* National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue
* Fevers \> 100.5 degrees or night sweats for \> 2 weeks without evidence of infection
* Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months
* No prior therapy for CLL/SLL, including che…
What they're measuring
1
Proportion of Patients Who Achieve an Antibody Response