Your session is about to expire
← Back to Search
Chemotherapy Agent
Roflumilast + R-CHOP for Lymphoma
Phase 1
Waitlist Available
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically proven diffuse large B-cell lymphoma.
No prior systemic therapy for lymphoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 3 weeks for 21 day cycles for the duration of study treatment, from baseline to approximately one year
Awards & highlights
Study Summary
This trial will study a new drug for people with aggressive lymphoma (cancer) and compare results to past cases.
Who is the study for?
Adults with untreated diffuse large B-cell lymphoma at moderate/high risk (NCCN-IPI score ≥2) can join. They must have a life expectancy of over 3 months, measurable disease, and proper organ function. Pregnant/breastfeeding women, those with other active cancers or severe medical conditions, recent major surgery patients, or individuals on certain medications are excluded.Check my eligibility
What is being tested?
The trial is testing Roflumilast added to standard R-Chop chemoimmunotherapy in a single group of participants. Results will be compared to past data from similar patients who didn't receive Roflumilast to see if it improves outcomes.See study design
What are the potential side effects?
Roflumilast may cause weight loss, mood changes like depression, digestive issues such as diarrhea and nausea, headaches, back pain and flu-like symptoms. Standard chemotherapy side effects include fatigue, hair loss, infection risk increase and possible damage to organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with diffuse large B-cell lymphoma.
Select...
I have not had any drug treatments for lymphoma.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is at an advanced stage, but not the earliest or final stages.
Select...
I have a lymph node or cancer lesion larger than 1.5 cm and it shows up on PET scans.
Select...
My white blood cell count is healthy.
Select...
My hemoglobin level is at least 8 g/dL, with or without help from transfusions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured every 3 weeks for 21 day cycles for the duration of study treatment, from baseline to approximately one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every 3 weeks for 21 day cycles for the duration of study treatment, from baseline to approximately one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-tumor efficacy: progression-free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: R-Chop and RoflumilastExperimental Treatment1 Intervention
All subjects will receive R-CHOP therapy at standard doses according to the standard preparation and infusion procedures of each investigational site, which is to be repeated every 21 days (+/- 3 days) for a total of 6 cycles. All subjects will receive a fixed oral dose of one 500 microgram (μg) tablet of roflumilast per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses. Subjects will be asked to keep a drug diary to record the days and times when Roflumilast is taken. The first dose will be given on the day of the first R-CHOP treatment.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,414 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My depression is not well-managed currently.I have no active cancer except for certain skin cancers or localized prostate cancer.I have not had any drug treatments for lymphoma.I have a lymph node or cancer lesion larger than 1.5 cm and it shows up on PET scans.I have no active cancer other than DLBCL.I haven't had cancer treatment or experimental therapy in the last 6 months.I agree to use birth control or abstain from sex during and 4 weeks after treatment.My hemoglobin level is at least 8 g/dL, with or without help from transfusions.The patient has agreed to the terms after being fully informed.I am not pregnant or breastfeeding.My lymphoma is classified as 'double-hit' or 'triple-hit'.I had a bone marrow transplant from another person within the last year.I had a stem cell transplant using my own cells within the last 6 months.My lymphoma affects my brain or spinal cord.I do not have any ongoing infections that aren't under control.I haven't had major surgery in the last 3 weeks or minor surgery in the last week.My heart test (BNP) levels are higher than normal for my age.I have hepatitis B or C but my liver tests are normal and I don't have active hepatitis.My liver function is moderately or severely impaired.I am currently taking certain medications that may affect the trial.I am currently taking medication for HIV.My white blood cell count is healthy.You have a platelet count of 50,000/μL or greater with or without transfusion support.Your NCCN-IPI risk score must be 2 or higher.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with diffuse large B-cell lymphoma.Your total bilirubin is no greater than 1.5 times the upper limit of normal (ULN) unless it is elevated because of Gilbert's syndrome or hemolysis.My cancer is at an advanced stage, but not the earliest or final stages.You have a life expectancy of at least three months.You are willing and capable of attending clinic visits and following the research protocol.Your left ventricle pumps out at least 45% of your total blood volume with each heartbeat, as determined through either ultrasound or radioisotope imaging.You are capable of ingesting oral tablets without hindrance.Your creatinine clearance is at least 30 ml/min according to the Cockcroft-Gault formula.You have a medical or psychiatric condition that could put you at risk or affect the study's ability to evaluate the safety of the medication, according to the investigator's judgment.
Research Study Groups:
This trial has the following groups:- Group 1: R-Chop and Roflumilast
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.
Is the eligibility criteria of this trial applicable to persons over 20 years old?
"This research endeavour is open to adults above 18 years of age and younger than 99."
Answered by AI
Are the potential dangers of R-Chop and Roflumilast in line with accepted medical safety standards?
"The safety of R-Chop and Roflumilast is rated a 1 on the scale due to there being limited information on their efficacy in this Stage 1 study."
Answered by AI
Do I fulfill the prerequisites to join this research project?
"Patients wishing to be part of this trial must have a diagnosis of b-cell lymphoma, and should fall between the ages 18 - 99. Ultimately, 90 individuals are needed for full participation in the study."
Answered by AI
Are there any slots available for this experiment, and if so how can one register to participate?
"According to clinicaltrials.gov, the recruitment period for this trial has ended and it is no longer seeking candidates. The investigation was initially posted on January 1st 2024 and its most recent update was on March 31st 2023. While this study cannot accept new participants at present, there are over 1700 other active trials currently enrolling patients."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger