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 range
18 Years – 79 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients Who Achieve an Antibody Response