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Alkylating agents

rituximab for Lymphoma

Phase 2

Waitlist Available

Led By Andrew M. Evens, DO, MS

Research Sponsored by ECOG-ACRIN Cancer Research Group

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 assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years

Awards & highlights

Study Summary

This trial is studying how well giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide works in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.

Eligible Conditions

Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 4 weeks during induction treatment and every 8 weeks during continuation treatment, up to 2 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

1-year Post-induction Disease-free Survival (DFS) Rate

Secondary outcome measures

1-year Disease-free Survival (DFS) Rate

3-year Progression-free Survival Rate

5-year Overall Survival Rate

+15 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C then Arm F (Induction with Bendamustine+Rituximab; Continuation with Lenalidomide + Rituximab)Experimental Treatment3 Interventions

Arm C (induction): Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm F (continuation): Immediately after completing induction therapy, patients who have stable disease or better at time of post-induction restaging receive oral lenalidomide on days 1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, these patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm B then Arm E (Induction with Bendamustine + Rituximab + Bortezomib; Continuation with Rituximab)Experimental Treatment3 Interventions

Arm B (induction): Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11; and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm E (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab as in arm D.

Group III: Arm A then Arm D (Induction with Bendamustine + Rituximab; Continuation with Rituximab)Experimental Treatment2 Interventions

Arm A (induction): Patients receive rituximab intravenously (IV) on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm D (continuation): Beginning 4 weeks after the completion of induction therapy, patients who have stable disease or better at time of post-induction restaging receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bendamustin

2011

Completed Phase 2

~290

bortezomib

2011

Completed Phase 3

~850

rituximab

2000

Completed Phase 3

~2760

lenalidomide

2012

Completed Phase 3

~3920

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,633 Total Patients Enrolled

9 Trials studying Lymphoma

5,682 Patients Enrolled for Lymphoma

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,230 Total Patients Enrolled

1,387 Trials studying Lymphoma

382,280 Patients Enrolled for Lymphoma

Andrew M. Evens, DO, MSPrincipal InvestigatorRobert H. Lurie Cancer Center

3 Previous Clinical Trials

72 Total Patients Enrolled

3 Trials studying Lymphoma

72 Patients Enrolled for Lymphoma

Frequently Asked Questions

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

How many participants are enrolled in this research investigation?

"Unfortunately, this study is not currently accepting patients. It was first published on December 13th 2010 and later edited on March 7th 2022. For those looking for other trials, there are 1719 studies recruiting for lymphoma and 726 seeking participants to test rituximab drugs."

Answered by AI

How many healthcare institutions are administering this experiment?

"Eligible patients may join this experiment at Saint Nicholas Hospital in Sheboygan, Wisconsin, Rocky Mountain Cancer Centers-Greenwood Village in Greenwood Village, Colorado and other 100 sites. Additionally, the trial site list includes Rocky Mountain Cancer Centers-Parker in Parker, Georgia."

Answered by AI

Is there precedent for experiments utilizing rituximab?

"The first trial for rituximab took place in 1993 at the National Institutes of Health Clinical Center located on 9000 Rockville Pike. Since then, 1467 trials have been finished and there are currently 726 studies actively recruiting patients - a large number of these being conducted in Sheboygan, Wisconsin."

Answered by AI

What ailments is rituximab principally utilized to combat?

"Rituximab is a common therapy for diffuse large B-cell lymphoma (DLBCL), and it has also been used to treat b-cell lymphomas, polyangium, and individuals with two prior chemotherapy regimens."

Answered by AI

What potential risks are associated with the utilization of rituximab?

"Based on our team's assessment, rituximab received a score of 2. This is because although there are some safety studies that have been conducted, no evidence has yet established its efficacy."

Answered by AI

Are patient participants still accepted for this clinical research?

"Unfortunately, this trial is not actively recruiting at the moment. Initially posted on December 13th 2010 and most recently updated on March 7th 2022, it has been removed from the list of studies for lymphoma (1719 trials) or rituximab (726 studies)."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

A Three-arm Randomized Phase II Study of Bendamustine/rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408

Evens, Andrew M., Fangxin Hong, Thomas M. Habermann, Ranjana H. Advani, Randy D. Gascoyne, Thomas E. Witzig, Andrew Quon, et al.. 2020. “A Three-arm Randomized Phase II Study of Bendamustine/rituximab with Bortezomib Induction or Lenalidomide Continuation in Untreated Follicular Lymphoma: ECOG-ACRIN E2408”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-20-1345.

clinicaltrials.govStudy

Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma

2011. "Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01216683.