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Alkylating agents

Rituximab for Non-Hodgkin's Lymphoma

Q: Are individuals still eligible to join the experiment?

Clinicaltrials.gov does not list this trial as recruiting participants at the moment; it was first posted in November of 2013 and last updated on April 18th 2022. Despite that, there are presently 3524 other clinical trials actively seeking enrolment.

Q: What ailments can Rituximab be employed to ameliorate?

Rituximab is a viable therapeutic option for those suffering from DLBCL, who have undergone at least two prior chemotherapy regimens, and other types of B-cell lymphomas.

Q: Are there limitations on the number of participants accepted in this trial?

This experiment has ended its recruitment phase; it was first posted on November 12th 2013 and last edited April 18th 2022. If you are still interested in participating clinical trials, 2877 studies involving <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> lymphocytic have open positions while 647 experiments concerning Rituximab require participants.

Q: Has Rituximab been granted regulatory clearance by the FDA?

Our team at Power rates Rituximab as a 2 on the safety scale because there is early evidence to suggest its security, but no information regarding efficacy due to being in Phase 2 of clinical trials.

Phase 2

Waitlist Available

Led By Julie Chang, MD

Research Sponsored by University of Wisconsin, Madison

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 least 24 months following completion of therapy, an average of 5 years

Awards & highlights

Study Summary

This trial will study a new treatment strategy for patients with CLL that involves 6 cycles of induction chemoimmunotherapy with rituximab + bendamustine, followed by initiation of maintenance rituximab and lenalidomide for patients who respond to the induction therapy.

Eligible Conditions

Non-Hodgkin's Lymphoma
Lymphocytic Leukemia
Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at least 24 months following completion of therapy, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at least 24 months following completion of therapy, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 24 months following completion of therapy, an average of 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to Progression

Secondary outcome measures

Count of Events Related to Toxicity

Objective Response Rates

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: Bendamustine, rituximab, lenalidomideExperimental Treatment3 Interventions

INDUCTION: Bendamustine 90mg/m2 IV D1&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity. MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 & <60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

Rituximab

1999

Completed Phase 4

~1880

Bendamustine

2015

Completed Phase 3

~2950

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor

444 Previous Clinical Trials

58,200 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,351 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,538 Previous Clinical Trials

567,692 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals still eligible to join the experiment?

"Clinicaltrials.gov does not list this trial as recruiting participants at the moment; it was first posted in November of 2013 and last updated on April 18th 2022. Despite that, there are presently 3524 other clinical trials actively seeking enrolment."

Answered by AI

What ailments can Rituximab be employed to ameliorate?

"Rituximab is a viable therapeutic option for those suffering from DLBCL, who have undergone at least two prior chemotherapy regimens, and other types of B-cell lymphomas."

Answered by AI

Are there limitations on the number of participants accepted in this trial?

"This experiment has ended its recruitment phase; it was first posted on November 12th 2013 and last edited April 18th 2022. If you are still interested in participating clinical trials, 2877 studies involving leukemia lymphocytic have open positions while 647 experiments concerning Rituximab require participants."

Answered by AI

Has Rituximab been granted regulatory clearance by the FDA?

"Our team at Power rates Rituximab as a 2 on the safety scale because there is early evidence to suggest its security, but no information regarding efficacy due to being in Phase 2 of clinical trials."

Answered by AI

Recent research and studies

British Journal of HaematologyJournal

Bendamustine + Rituximab Chemoimmunotherapy and Maintenance Lenalidomide in Relapsed, Refractory Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma: A Wisconsin Oncology Network Study

Chang, Julie E., Thomas Havighurst, KyungMann Kim, Jens Eickhoff, Anne M. Traynor, Rachel Kirby-Slimp, Lynn M. Volk, et al.. 2016. “Bendamustine + Rituximab Chemoimmunotherapy and Maintenance Lenalidomide in Relapsed, Refractory Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma: A Wisconsin Oncology Network Study”. British Journal of Haematology. Wiley. doi:10.1111/bjh.13957.

clinicaltrials.govStudy

Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL

2013. "Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01754857.