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Corticosteroid

Rituximab for MALT Lymphoma

Phase 2

Waitlist Available

Led By Stephen J Schuster, MD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

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 9 years from enrollment of first subject

Awards & highlights

Study Summary

This trial is testing whether adding lenalidomide and dexamethasone to rituximab can help people with small B-cell non-Hodgkin lymphoma who have had lymphoma progression after being treated with rituximab alone.

Eligible Conditions

MALT Lymphoma
Waldenstrom Macroglobulinemia
Marginal Zone Lymphoma
Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 years from enrollment of first subject

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 years from enrollment of first subject

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 years from enrollment of first subject for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dexamethasone

Secondary outcome measures

Time Until Progression After Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphomas With Rituximab Resistance

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lenalidomide plus rituximab with dexamethasoneExperimental Treatment3 Interventions

Lenalidomide-low dose dexamethasone plus rituximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Rituximab

1999

Completed Phase 4

~1880

Lenalidomide

2005

Completed Phase 3

~1480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,014 Total Patients Enrolled

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,614 Total Patients Enrolled

Stephen J Schuster, MDPrincipal InvestigatorUniversity of Pennsylvania

2 Previous Clinical Trials

649 Total Patients Enrolled

Frequently Asked Questions

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

In what scenarios is Rituximab a viable therapeutic option?

"Rituximab is a popular medication for the treatment of ophthalmic and sympathetic conditions, in addition to branch retinal vein occlusion, macular edema, and malignancies that have not responded to at least two prior systemic chemotherapy regimens."

Answered by AI

What is the level of risk associated with Rituximab for humans?

"The safety of Rituximab has been provisionally rated a 2, as it is only in the second stage of clinical trials and studies have demonstrated its security rather than efficacy."

Answered by AI

Is enrollment now open for this experiment?

"According to the recent details on clinicaltrials.gov, this study is not presently recruiting participants despite its initial posting back in July 2008 and last update of June 2022. Nonetheless, there are 2,926 other trials actively searching for volunteers right now."

Answered by AI

Are there any precedential investigations utilizing Rituximab?

"Currently, there are 1013 clinical trials actively researching Rituximab, 238 of which have surpassed the third stage. The epicentre for this treatment is Joliet, Illinois and these studies are being conducted across a total of 35 611 sites."

Answered by AI

How many participants are currently being monitored for this research endeavor?

"At the present moment, no patients are being sought for this trial. This research was initially posted on July 1st 2008 and recently updated on June 3rd 2022. However, if you're looking to participate in another study, there are 1913 trials actively recruiting participants with malt lymphoma and 1013 studies admitting candidates for Rituximab treatment."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Rituximab Chimeric Anti-cd20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-dose Treatment Program.

McLaughlin, P, A J Grillo-López, B K Link, R Levy, M S Czuczman, M E Williams, M R Heyman, et al.. 1998. “Rituximab Chimeric Anti-cd20 Monoclonal Antibody Therapy for Relapsed Indolent Lymphoma: Half of Patients Respond to a Four-dose Treatment Program.”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.1998.16.8.2825.

Journal of Clinical OncologyJournal

Rituximab Anti-cd20 Monoclonal Antibody Therapy in Non-hodgkin’s Lymphoma: Safety and Efficacy of Re-treatment

Davis, Thomas A., Antonio J. Grillo-López, Christine A. White, Peter McLaughlin, Myron S. Czuczman, Brian K. Link, David G. Maloney, Robin L. Weaver, Jay Rosenberg, and Ronald Levy. 2000. “Rituximab Anti-cd20 Monoclonal Antibody Therapy in Non-hodgkin’s Lymphoma: Safety and Efficacy of Re-treatment”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2000.18.17.3135.

BloodJournal

CD20 Levels Determine the in Vitro Susceptibility to Rituximab and Complement of B-cell Chronic Lymphocytic Leukemia: Further Regulation by CD55 and CD59

Golay, Josée, Manuela Lazzari, Valeria Facchinetti, Sergio Bernasconi, Gianmaria Borleri, Tiziano Barbui, Alessandro Rambaldi, and Martino Introna. 2001. “CD20 Levels Determine the in Vitro Susceptibility to Rituximab and Complement of B-cell Chronic Lymphocytic Leukemia: Further Regulation by CD55 and CD59”. Blood. American Society of Hematology. doi:10.1182/blood.v98.12.3383.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal