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Alkylating agents
Split-Dose R-CHOP for Lymphoma
Phase 2
Recruiting
Led By Christopher Fletcher, 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
Karnofsky Performance Score ≥50
Ann Arbor Stage II bulky, III, or IV disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 6 months
Awards & highlights
Study Summary
This trial is testing a new way to give R-CHOP chemotherapy to elderly people with DLBCL. It will last 2.5 years and people may be eligible if they are aged 70-74.
Who is the study for?
This trial is for older adults aged 75+ with untreated Diffuse Large B-Cell Lymphoma (DLBCL). Some individuals aged 70-74 may qualify if they are unfit or frail. Participants must have a good heart function, no severe liver issues, and not be HIV positive. Prior low-grade NHL treatment without anthracyclines is okay. Exclusions include recent heart attack, CNS involvement by lymphoma, very poor kidney function, active second cancer within the last two years, and certain infections.Check my eligibility
What is being tested?
The study tests a split-dose R-CHOP chemotherapy regimen in elderly patients with DLBCL to see if it's effective and tolerable. R-CHOP includes Rituximab plus four other drugs: Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. The trial lasts for about 2.5 years including follow-up after six months of treatment.See study design
What are the potential side effects?
Possible side effects from the chemotherapy can include nausea and vomiting; hair loss; fatigue; increased risk of infection due to lower white blood cells; anemia causing tiredness or shortness of breath; bleeding problems from low platelets; nerve damage leading to numbness or tingling; heart damage especially from Doxorubicin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to live at home and care for most of my personal needs.
Select...
My cancer is at an advanced stage according to the Ann Arbor classification.
Select...
I have had treatment for low-grade NHL without using anthracycline drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate (CR)
Secondary outcome measures
Cancer-Specific Geriatric Assessment
Incidence of Treatment Emergent Adverse Events
Overall Survival (OS)
+1 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Split Dose R-CHOPExperimental Treatment6 Interventions
Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for 6 cycles
Day 1 ("A" part of cycle)
Rituximab 375 mg/m2 IV (or biosimilars Ruxience or Truxima)
Cyclophosphamide 375 mg/m2 IV
Doxorubicin 25 mg/m2 IV
Vincristine 1 mg IV
Prednisone 50 mg (Days 1-5) PO
Pegfilgrastim (supportive care) 6 mg on Day 2 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Day 15 ("B" part of cycle)
Cyclophosphamide 375 mg/m2 IV
Doxorubicin 25 mg/m2 IV
Vincristine 1 mg IV
Prednisone 50 mg (Days 15-19) PO
Pegfilgrastim (supportive care) 6 mg on Day 16 (24 hours after completion of chemotherapy) or filgrastim daily as institutionally indicated (starting 24 hours post completion of chemotherapy), or institutional standard granulocyte stimulating factor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Vincristine
2003
Completed Phase 4
~2910
Pegfilgrastim
2013
Completed Phase 3
~4410
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Medical College of WisconsinOTHER
610 Previous Clinical Trials
1,162,687 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,520 Total Patients Enrolled
Nirav Shah, MD, MSStudy ChairMedical College of Wisconsin Clinical Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hepatitis C antibodies but my viral load is negative.I have had cancer before, but I haven't needed chemotherapy for it in the last 2 years.My cancer has spread to my brain or its coverings.I have hepatitis B but my viral load is negative and I'm following a prevention plan during chemotherapy.I do not have any active, uncontrolled infections.My cancer can be measured by scans or a bone marrow test.My kidney function is low, with a creatinine clearance under 25 mL/min.My liver isn't working well, but it's not because of my lymphoma.I cannot or do not want to sign the consent form.I do not have other bone marrow cancers or very low blood cell counts, unless it's due to lymphoma.I am able to live at home and care for most of my personal needs.I am 70 or older and considered unfit or frail by a health assessment.My doctor may decide if I need specific chemotherapy for brain protection.I have a specific type of untreated lymphoma that tests positive for CD20.My cancer is at an advanced stage according to the Ann Arbor classification.You have taken any experimental medication within the past month before starting chemotherapy.I need more than 2 liters of oxygen to keep my oxygen levels above 90%, not due to lymphoma.I am 70-74 with moderate to severe health conditions besides my cancer.I have not had a heart attack in the last 6 months.I have been treated with anthracycline drugs before.I have had treatment for low-grade NHL without using anthracycline drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Split Dose R-CHOP
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.
What medical ailment is Rituximab routinely used to treat?
"Rituximab is widely used to treat lung cancers, but can also be prescribed as a treatment for small cell lung cancer (sclc), thyroiditis and polyangium."
Answered by AI
Are there still vacancies available for participation in this investigation?
"Affirmative. Per clinicaltrials.gov, this medical trial is currently recruiting participants and was first posted on February 16th 2021 with the most recent edit made October 4th 2022. The study requires 46 patients from one site to complete enrollment."
Answered by AI
Has the Food and Drug Administration sanctioned Rituximab as a safe treatment?
"Rituximab, which is being tested in Phase 2 clinical trials, has been evaluated for its safety and received a score of 2. As yet, no data exists to support the efficacy of this drug."
Answered by AI
What other experimental trials have utilized Rituximab?
"Presently, 1507 studies are underway researching the efficiency of Rituximab. Of these trials, 327 have passed into Phase 3 experimentation. Although most facilities conducting research on this medication are situated in Bethesda, Maryland; there exist 54 042 sites across the globe running clinical experiments with Rituximab."
Answered by AI
How many participants has this trial recruited thus far?
"Affirmative, the clinical trial is actively searching for participants according to information on clinicaltrials.gov. It was initially posted on February 16th 2021 and most recently updated October 4th 2022. The study requires 46 volunteers from one location."
Answered by AI
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