Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, … (NCT02005289) | Clinical Trial Compass
CompletedPhase 2
Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL
United States41 participantsStarted 2014-01-17
Plain-language summary
This phase II trial studies how well anti-cluster of differentiation (CD)19 monoclonal antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia. Monoclonal antibodies, such as anti-CD19 monoclonal antibody MOR00208, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-CD19 monoclonal antibody MOR00208 and lenalidomide may kill more cancer cells.
Who can participate
Age range
18 Years – 80 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 with a diagnosis of intermediate or high risk CLL, SLL, or B cell (B)-PLL by Biennial International Workshop on CLL (IWCLL) 2008 criteria who have
* COHORT 1: previously untreated disease AND refuse or are ineligible for approved chemo- and/or -immunotherapy options for untreated CLL/SLL/PLL
* COHORT 2: previously received at least one therapy for their disease
* All patients must satisfy one of the following criteria for active disease requiring therapy:
* Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
* Massive (\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
* Massive nodes (\>= 10 cm) or progressive or symptomatic lymphadenopathy
* Constitutional symptoms, which include any of the following:
* Unintentional weight loss of 10% or more within 6 months
* Significant fatigue limiting activity
* Fevers \>= 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection
* Night sweats \> 1 month without evidence of infection
* Patients with a history of Richter's transformation are eligible if they now have evidence of CLL only, with \< 10% large cells in the bone marrow
* Creatinine =\< 2
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal
* Bilirubin =\< 2 times the upper limit of normal, unless relat…
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 a response (i.e. CR, complete response with incomplete recovery [CRi], nPR, or PR), as defined according to the IWCLL 2008 criteria
Timeframe: up to 6 months
Trial details
NCT IDNCT02005289
SponsorOhio State University Comprehensive Cancer Center