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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Changes in IL-21R expression

Changes in expression of select genes associated with B-cell activation

Effects of combined therapy with MOR00208 and lenalidomide on CD4+ T cells using flow cytometry during the course of protocol therapy

+12 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,126 Total Patients Enrolled

20 Trials studying Lymphoma

421 Patients Enrolled for Lymphoma

MorphoSys AGIndustry Sponsor

26 Previous Clinical Trials

6,619 Total Patients Enrolled

11 Trials studying Lymphoma

5,899 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

Lenalidomide (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02005289 — Phase 2

Lymphoma Research Study Groups: Cohorts 1-3Treatment (MOR00208, lenalidomide), Cohort 4 Treatment (MOR00208, ibrutinib)

Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT02005289 — Phase 2

Lenalidomide (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02005289 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study have any age restrictions?

"This study is inclusive of patients that are young as 18 and older than 80."

Answered by AI

Does MOR00208 have regulatory approval for use in the United States?

"MOR00208's score of 2 reflects that, while there is some data affirming its safety, there is no evidence yet as to whether the medication works."

Answered by AI

Are we still enrolling people in this experiment?

"Unfortunately, this particular clinical trial is not looking for new participants. The original posting was on January 17th, 2014 with the most recent update being February 24th, 2022. However, there are 3227 other trials that are actively seeking candidates."

Answered by AI

What are the common illnesses that MOR00208 has been shown to be effective against?

"MOR00208 is most commonly used as treatment for at least two prior systemic chemotherapy regimens. It can also be taken to treat various conditions including amyloidosis, b-cell lymphomas, and muscular dystrophy."

Answered by AI

What is the quota for participants in this experiment?

"This trial is not currently enrolling patients. This study was first posted on 1/17/2014 and most recently updated on 2/24/2022. However, there are 2950 other trials for chronic lymphocytic leukemia and 277 MOR00208 studies recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jennifer Woyach 2014. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02005289.

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