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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
3-year Progression-free Survival Rate
Secondary outcome measures
Overall Survival Rate at 3 Years
Proportion of Patients With Complete Response
Proportion of Patients With Response
Other outcome measures
Impact of DLBCL Molecular Subtype on Outcome.
Interim PET Scan Results in Relation to Treatment Outcome
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
1995
Completed Phase 3
~3780
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Lenalidomide
2005
Completed Phase 3
~1480
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Vincristine Sulfate
2005
Completed Phase 3
~10110
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,804 Total Patients Enrolled
Grzegorz S NowakowskiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I have a tumor tissue sample from my initial biopsy ready for analysis.I am willing and able to take blood thinning medication as prescribed.I do not have AIDS or conditions related to it, and if HIV positive, I am on certain antiretrovirals with a CD4 count over 400.I have no active cancer needing treatment, except for possibly treated skin cancer or another cancer considered cured.I haven't had cancer in the last 5 years, except for skin cancer.My cancer is at an advanced stage or has a large tumor over 10 cm.I am not taking any medications to increase my red blood cells.I have DLBCL with CD20, no transformed or primary mediastinal type, and c-myc status doesn't exclude me.I am able to get out of my bed or chair and move around.I have lymphoma and haven't started any treatment yet, but I may have taken steroids for symptoms.I don't have cancer in my brain or spinal cord.I don't have a history of serious blood clots, or I'm willing to take strong blood thinners if needed.I haven't had a heart attack in the last 6 months or heart failure needing constant treatment.I haven't had radiation on a large part of my bone marrow or anthracycline therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (rituximab, combination chemotherapy, lenalidomide)
- Group 2: Arm B (rituximab, combination chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many health care facilities in the United States are involved with this research endeavor?
"Currently, this medical study is accepting participants at 100 clinics across the US. Fort Sam Houston, Mishawaka and Las Vegas are locations that offer recruitment services for this trial; however, there are many additional sites available to decrease travel burden."
Answered by AI
What medical conditions have lenalidomide been known to address?
"Lenalidomide has demonstrated effectiveness in treating pheochromocytomas, ulcerative colitis, and cases of varicella-zoster virus induced acute retinal necrosis."
Answered by AI
Are there any openings for participation in this experiment?
"At this time, the trial is not accepting additional patients. It was initially posted on August 27th 2013 and most recently revised on September 23rd 2022. Currently, 1766 medical studies are actively recruiting participants with lymphoma/B-cell while 1682 trials involving lenalidomide have open enrolment opportunities."
Answered by AI
Has the Federal Drug Administration certified Lenalidomide for medical use?
"Lenalidomide has some evidence for safety, so it was allocated a score of 2. As this is only Phase 2 data however, no proof exists to validate its efficacy."
Answered by AI
Are there any other previous investigations that focus on Lenalidomide?
"Currently, there are 1682 Lenalidomide trials that have been activated, with 371 of these within Phase 3. Across the globe, 63640 sites are collect data from and administering treatment for this drug. The majority of studies occur in Joliet, Illinois."
Answered by AI
How many individuals are eligible to participate in this trial?
"At the moment, enrollment for this clinical trial is no longer available. The study was initially posted on August 27th 2013 and last updated on September 23rd 2022; however, if you are looking to participate in a similar investigation regarding lymphoma or Lenalidomide there are 1,766 and 1,682 respective trials recruiting patients right now."
Answered by AI
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