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Bruton's Tyrosine Kinase (BTK) Inhibitor

Rituximab for Mantle Cell Lymphoma

Phase 1
Waitlist Available
Led By Andre Goy, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years
Histologically or cytologically confirmed diagnosis of MCL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat mantle cell lymphoma, a type of blood cancer.

Who is the study for?
This trial is for adults over 18 with Mantle Cell Lymphoma that has come back or hasn't responded to treatment. They must have had at least one prior therapy, be in decent physical shape (ECOG ≤2), and have certain blood counts within normal ranges. Women who can have children need a negative pregnancy test and must follow specific safety programs.Check my eligibility
What is being tested?
The study aims to find the safest dose of Ibrutinib combined with Lenalidomide/Rituximab for patients with relapsed/refractory Mantle Cell Lymphoma. It's a step-by-step process where doses are increased to determine the maximum tolerated dose or recommended phase II dose.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system suppression such as infections, bleeding issues due to low platelets, anemia from low red blood cells, fatigue, kidney problems, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My diagnosis of mantle cell lymphoma (MCL) is confirmed by lab tests.
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My kidney function is normal, with a creatinine level below 2.
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I have MCL and have been treated before, but my condition didn't improve or has returned.
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My daily activity is significantly limited due to my health.
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My blood tests show normal organ function and I don't have severe anemia or liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study
This trial's timeline: 3 weeks for screening, Varies for treatment, and response is evaluated after 2, 4 and 6 cycles, after initiation of treatment and later every 3 cycles until disease progression or patient taken off study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the MTD (Measured in mg) Based on the Number of Patients With Adverse Events
Secondary outcome measures
Assess Drug-drug Interaction of Combination Therapy
Assess Radiologic Progression-Free Survival
Assess Radiologic Response Rate
+1 more

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation StudyExperimental Treatment3 Interventions
Ibrutinib 560 mg/daily rituximab 375mg/m2 IV Day 1 Lenalidomide 10-25 mg PO days 1-21
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Lenalidomide
2005
Completed Phase 3
~1480
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,217 Total Patients Enrolled
Andre Goy, MDPrincipal InvestigatorHackensack Meridian Health
5 Previous Clinical Trials
238 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~3 spots leftby Mar 2025