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Chemotherapy + Carfilzomib for Lymphoma
Study Summary
This trial is studying carfilzomib given with rituximab, ifosfamide, carboplatin, and etoposide to see how well it works and what the side effects are.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a tumor that can be measured and is at least 2.25 cm^2 in size.I have active brain or spinal cord lymphoma but am still eligible if a specific test shows DLBCL at registration.My lymphoma has returned or didn't respond to treatment and tests positive for CD20.My kidney function is normal or meets the trial's requirements.I agree to regular pregnancy tests and will use birth control during the study.My heart's pumping ability is normal, confirmed by a heart scan.I have hepatitis C but my liver tests are within acceptable limits and I don't have cirrhosis.I do not have active hepatitis B but am immune to it.My hemoglobin level is at least 8 g/dL recently.My platelet count meets the required level for therapy.I have tested positive for hepatitis B surface antigen or have hepatitis B core antibodies with a negative DNA test.I have symptoms from cancer spreading to my brain.My condition is non-Hodgkin lymphoma, not including DLBCL.I have undergone high-dose chemotherapy with stem cell transplant.I have been cancer-free for at least 2 years, except for certain low-risk types or treated localized prostate cancer.I have not had major surgery in the last 2 weeks.I do not have any serious illnesses that could affect my participation in the study.I am allergic to Captisol.I am on long-term high dose steroids (more than 10 mg/day of prednisone or equivalent).My DLBCL is between stage I and IV and has come back or not responded to treatment.I have moderate to severe nerve pain or damage.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I agree to use birth control methods.I have had at least one treatment that included rituximab for my condition.It has been more than 2 weeks since I had major surgery.I don't have major side effects from past cancer treatments.I am able to live at home and care for most of my personal needs.I tested negative for HBsAg but positive for HBcAb, and I've had a HBV DNA test.I will get HBV DNA tests every 2 months during treatment.My liver tests are within the required range.I haven't had chemotherapy in the last 3 weeks.
- Group 1: Treatment (carfilzomib, rituximab, chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many individuals are currently participating in this clinical research?
"Unfortunately, this particular clinical trial is no longer recruiting participants. It was first published in April 2014 and its latest edit occured in July 2022. Fortunately, there are 1767 investigational studies seeking b-lymphocyte patients and 1875 trials that use Carfilzomib actively searching for study members."
Who is eligible to participate in this trial?
"This research requires 29 individuals, aged 18 to 75, with b-lymphocytes. Furthermore, the Principal Investigator (PI) exercises discretion in determining if participants display any significant toxicity related to prior treatments such as surgery and chemotherapy. Additionally, those who wish to join must demonstrate measurable or assessable disease through a CT scan or physical exam; have a Karnofsky score of 50 or above; and boast an expected life expectancy of at least three months from entry."
What are the key goals of this research endeavor?
"This clinical trial will measure the Overall Response Rate (PR + CR) of participants over a 28-day period as its primary outcome. Secondary outcomes include Overall Survival, estimated with Kaplan-Meier method and compared between groups using log rank test; Pharmacokinetics/Pharmacodynamics of Carfilzomib & Standard RICE Combination Therapy in Adult Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma, explored through NONMEM population PK/PD models; and Progression Free Survival, assessed by Kaplan-Meier analysis and Cox proportional hazards model regression."
To what end is Carfilzomib typically deployed?
"Merkel cell cancer is best managed with Carfilzomib, a medication that can also prove effective for leukemia, primary treatment, and prostate tumours."
Are octogenarians accepted as participants in this research?
"This medical trial seeks applicants aged 18 to 75. 684 clinical trials are available for minors, while 3214 studies accommodate seniors over the age of 65."
Has Carfilzomib gone through the necessary regulatory processes for commercialization?
"The safety score of Carfilzomib was assigned a 1 as it is an early stage trial, with only preliminary evidence supporting its efficacy and limited data verifying the drug's security."
Are there any previous studies involving Carfilzomib that have been conducted?
"Presently, 1875 Carfilzomib studies are being conducted worldwide with 441 of them in their penultimate Phase 3. While the primary research location is Bethesda, Maryland an impressive 80,747 sites have been utilized to investigate this medication."
Are recruitments still underway for this clinical experiment?
"Though this trial was initially posted in April of 2014, it is no longer recruiting patients. The last update to the listing on clinicaltrials.gov occurred on July 19th 2022; however, there are still 3642 studies actively seeking participants at present."
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