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Glofitamab Combo vs Rituximab Combo for Diffuse Large B-Cell Lymphoma
Study Summary
This trial will compare the effectiveness of two different combinations of drugs for treating patients with relapsed or refractory diffuse large B cell lymphoma.
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.Side effects data
From 2021 Phase 1 trial • 23 Patients • NCT04313608Trial Design
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Who is running the clinical trial?
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- My disease came back or didn't respond to treatment within 6 months of my last therapy.I have or might have a long-term Epstein-Barr virus infection.My condition is primary mediastinal B-cell lymphoma.I cannot take obinutuzumab, rituximab, gemcitabine, oxaliplatin, or tocilizumab due to adverse reactions.I have a tumor that can be measured on a CT scan.I haven't had cancer treatments like radiotherapy or chemotherapy in the last 2 weeks.I do not have any current infections or major infections in the last 4 weeks.My lymphoma is high-grade with specific genetic changes.My diagnosis is diffuse large B-cell lymphoma.I have had one treatment for my condition and am not eligible for high-dose chemotherapy with a stem cell transplant.I tested positive for COVID-19 in the last 30 days.I have or might have had HLH.I have been diagnosed with progressive multifocal leukoencephalopathy.I have had one treatment for my condition and am eligible for a stem cell transplant.I have a significant history of liver disease.I have had a stem cell transplant from a donor.I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.I have not been treated with glofitamab or similar drugs.I do not have severe nerve damage.My blood counts are within normal ranges, not affected by my condition.I have had at least one treatment for my condition.I might have tuberculosis.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.My slow-growing cancer has changed into aggressive large B-cell lymphoma.I have or had lymphoma in my brain or spinal cord.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I haven't taken any immune-weakening medications in the last 4 weeks.I can take care of myself and am up and about more than half of my waking hours.I haven't taken corticosteroids in the last 2 weeks.I have or had a brain-related condition like stroke or epilepsy.I have had a solid organ transplant.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.I can provide a sample of my tumor for testing, either new or from past surgeries.My side effects from previous cancer treatments have mostly gone away.I am currently being treated for an autoimmune disease.
- Group 1: R-GemOx
- Group 2: Glofit-GemOx
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is there still room for more participants in this clinical trial?
"Yes, the information on clinicaltrials.gov confirms that this trial is currently looking for patients. The trial was originally posted on February 23rd, 2021 and was most recently edited on October 11th, 2022. The trial is searching for 270 patients at 12 locations."
Does Glofitamab have any negative side effects?
"Glofitamab's safety was evaluated by our team at Power, and it received a score of 3. A Phase 3 trial design was chosen for this medication, which is the highest level of support for efficacy and safety."
What are the conditions that Glofitamab has been most effective in ameliorating?
"small cell lung cancer (sclc) is most commonly treated with Glofitamab. Glofitamab can also be useful for treating other conditions such as systemic juvenile idiopathic arthritis (sjia), head and neck carcinoma, and cervical cancers."
With what other therapies has Glofitamab been compared in scientific trials?
"Currently, there are 920 ongoing clinical trials studying Glofitamab with 271 of those in Phase 3. The majority of these Glofitamab trials are based in Guangzhou, Guangdong; however, there are a total of 43355 locations worldwide where Glofitamab trials are taking place."
How many different people are being helped by this clinical trial?
"Yes, up-to-date information on clinicaltrials.gov reveals that this study is still actively enrolling patients. The trial was originally posted on February 23rd, 2021 and was last updated on October 11th, 2022. The trial is looking for a total of 270 participants, to be recruited from 12 different sites."
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