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Anti-tumor antibiotic, Anti-metabolites

Rituximab + Chemotherapy +/- Lenalidomide for Lymphoma

Phase 2

Waitlist Available

Led By Grzegorz S Nowakowski

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV (Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded from this study

Patient must be able and willing to receive anticoagulation therapy with aspirin 70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing rituximab and combination chemotherapy with or without lenalidomide to treat patients with newly diagnosed stage II-IV diffuse large B cell lymphoma to see if it is more effective with or without lenalidomide.

Who is the study for?

This trial is for adults with newly diagnosed stage II-IV diffuse large B cell lymphoma. Participants must have a performance status of 0-2, meaning they can perform daily activities without significant limitations. They should not have had previous treatments for lymphoma or other active cancers requiring therapy, no history of heart issues like recent myocardial infarction, and be able to take blood thinners if necessary.

What is being tested?

The study is testing the effectiveness of rituximab combined with chemotherapy drugs (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone) versus the same combination with an additional drug called lenalidomide. The goal is to see which regimen works better at treating diffuse large B cell lymphoma.

What are the potential side effects?

Possible side effects include reactions to monoclonal antibodies like rituximab (e.g., fever, chills), low blood counts leading to increased infection risk or bleeding tendencies from chemotherapy drugs, and potential risks associated with lenalidomide such as blood clots or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is at an advanced stage or has a large tumor over 10 cm.

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I am willing and able to take blood thinning medication as prescribed.

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I am not taking any medications to increase my red blood cells.

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I am able to get out of my bed or chair and move around.

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I haven't had a heart attack in the last 6 months or heart failure needing constant treatment.

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I haven't had radiation on a large part of my bone marrow or anthracycline therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year pfs rate reported

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year pfs rate reported

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year pfs rate reported for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

3-year Progression-free Survival Rate

Secondary study objectives

Overall Survival Rate at 3 Years

Proportion of Patients With Complete Response

Proportion of Patients With Response

Other study objectives

Interim PET Scan Results in Relation to Treatment Outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (rituximab, combination chemotherapy, lenalidomide)Experimental Treatment7 Interventions

Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (rituximab, combination chemotherapy)Active Control6 Interventions

Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860