Lenalidomide for Non-Hodgkin's Lymphoma

Local Institution - 077, Little Rock, AR
Lenalidomide +1 morePhase 3Waitlist AvailableResearch Sponsored by Celgene

Study Summary

This trial is testing the combination of lenalidomide and rituximab to see if it is more effective in treating NHL than lenalidomide alone.

Eligible Conditions
  • Non-Hodgkin Lymphoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
Your condition has not improved or has gotten worse after your last treatment with medicines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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
Progression free survival (PFS) for Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL)
Secondary outcome measures
Adverse Events
Complete response rate
Duration of complete response
+6 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Lenalidomide + rituximab followed by lenalidomideExperimental Treatment2 Interventions
Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by an optional Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses
Group II: Arm B: Lenalidomide + rituximab followed by rituximabActive Control2 Interventions
Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Rituximab
FDA approved

Find a site

Who is running the clinical trial?

CelgeneLead Sponsor
627 Previous Clinical Trials
125,828 Total Patients Enrolled
Mecide Gharibo, MDStudy Director
Celgene
2 Previous Clinical Trials
Bristol-Myers SquibbStudy Director
Bristol-Myers Squibb
1,460 Previous Clinical Trials
3,318,525 Total Patients Enrolled

Media Library

Lenalidomide Clinical Trial Eligibility Overview. Trial Name: NCT01996865 — Phase 3
Non-Hodgkin's Lymphoma Research Study Groups: Arm A: Lenalidomide + rituximab followed by lenalidomide, Arm B: Lenalidomide + rituximab followed by rituximab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01996865 — Phase 3
Lenalidomide 2023 Treatment Timeline for Medical Study. Trial Name: NCT01996865 — Phase 3

Frequently Asked Questions

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

Is this study still enrolling new participants?

"Data from clinicaltrials.gov suggests that this particular trial is not currently recruiting patients. The study was initially posted on April 1st, 2014 but was last edited on October 25th, 2020. There are 2419 other trials seeking patients at the moment."

Answered by AI

Are there any dangers associated with Rituximab?

"There is some clinical evidence in support of Rituximab's efficacy, as well as multiple rounds of safety data, so it received a score of 3."

Answered by AI

What is the general research consensus on Rituximab's effectiveness?

"Rituximab was first studied in 1993 at National Institutes of Health Clinical Center. So far, there have been 1105 completed studies with 628 trials actively recruiting patients. Many of these locations are based out of Park Ridge, Illinois."

Answered by AI

What are some of Rituximab's primary functions?

"Rituximab is most often used to treat diffuse large b-cell lymphoma (dlbcl), however, it has also been found effective in treating other conditions such as at least two prior systemic chemotherapy regimens, b-cell lymphomas, and polyangium."

Answered by AI

How many individuals are involved in this clinical trial?

"This particular study is no longer looking for volunteers. It was originally posted on April 1st, 2014 but has not been updated since October 25th, 2022. However, there are currently 1791 trials actively recruiting participants with lymphoma and 628 trials involving Rituximab that are still admitting patients."

Answered by AI

Can you tell me how many different hospitals are participating in this clinical trial?

"There are 100 sites participating in this study, including Oncology Specialists, PC in Park Ridge, Sparrow Hospital and Health System in Lansing, Local Institution - 050 in Bolivar, and other locations."

Answered by AI
Recent research and studies
Journal of Clinical OncologyJournal
AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma
Leonard, John P., Marek Trneny, Koji Izutsu, Nathan H. Fowler, Xiaonan Hong, Jun Zhu, Huilai Zhang, et al.. 2019. “AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.00010.
British Journal of HaematologyJournal
Lenalidomide Plus Rituximab (r<sup>2</sup>) in Previously Untreated Marginal Zone Lymphoma: Subgroup Analysis and Long‐term Follow‐up of an Open‐label Phase 2 Trial
Becnel, Melody R., Loretta J. Nastoupil, Felipe Samaniego, Richard E. Davis, M. J. You, Michael Green, Fredrick B. Hagemeister, et al.. 2019. “Lenalidomide Plus Rituximab (r2) in Previously Untreated Marginal Zone Lymphoma: Subgroup Analysis and Long‐term Follow‐up of an Open‐label Phase 2 Trial”. British Journal of Haematology. Wiley. doi:10.1111/bjh.15843.
clinicaltrials.govStudy
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
2014. "Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01996865.
All > Mantle Cell Lymphoma > Revlimid
~0 spots leftby Oct 2023
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