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Anti-metabolites
MOR00208 + Lenalidomide for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Jennifer Woyach, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
Summary
This trial is studying how well anti-CD19 monoclonal antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia that's come back or hasn't been treated. They should have symptoms like weight loss, fatigue, fever without infection, large spleen or lymph nodes. They need to be in good enough health to take pills and not have other serious illnesses or cancers that would interfere with the study.
What is being tested?
Researchers are testing a combination of MOR00208 (an antibody targeting cancer cells) and lenalidomide (a drug that may boost the immune system) to see if they work better together against certain blood cancers. The trial will look at how well patients respond to this treatment combo.
What are the potential side effects?
Possible side effects include reactions where the drugs enter the body, changes in blood counts leading to increased risk of infections or bleeding, tiredness, liver issues indicated by altered blood tests results and potential impact on organ function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Effects of combined therapy with MOR00208 and lenalidomide on CD4+ T cells using flow cytometry during the course of protocol therapy
Effects of combined therapy with MOR00208 and lenalidomide on CD8+ T cells during the course of protocol therapy by flow cytometry
Effects of combined therapy with MOR00208 and lenalidomide on NK cells during the course of protocol therapy by flow cytometry
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohorts 1-3Treatment (MOR00208, lenalidomide)Experimental Treatment3 Interventions
Patients receive anti-CD19 monoclonal antibody MOR00208 IV over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1 only) and lenalidomide PO daily on days 1-28 (days 9-28 of course 1 only). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Correlative studies will be collected for this trial and will focus on the effects of MOR00208 alone and in combination with lenalidomide on immune effector cell number and function.
Group II: Cohort 4 Treatment (MOR00208, ibrutinib)Experimental Treatment2 Interventions
Patients receive anti-CD19 monoclonal antibody MOR00208 IV over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1 only) and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Correlative studies will be collected for this trial and will focus on the effects of MOR00208 alone and in combination with ibrutinib on immune effector cell number and function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lenalidomide
2012
Completed Phase 3
~3920
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
334 Previous Clinical Trials
291,567 Total Patients Enrolled
21 Trials studying Lymphoma
397 Patients Enrolled for Lymphoma
MorphoSys AGIndustry Sponsor
26 Previous Clinical Trials
6,555 Total Patients Enrolled
11 Trials studying Lymphoma
5,835 Patients Enrolled for Lymphoma
Jennifer Woyach, MDPrincipal InvestigatorThe Ohio State University Comprehensive Cancer Center
4 Previous Clinical Trials
112 Total Patients Enrolled
3 Trials studying Lymphoma
97 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Cohorts 1-3Treatment (MOR00208, lenalidomide)
- Group 2: Cohort 4 Treatment (MOR00208, ibrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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