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Obinutuzumab + Ibrutinib for Indolent Non-Hodgkin's Lymphomas
Study Summary
This trial is testing a new therapy for non-Hodgkin's lymphoma that could be more effective than current treatments.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 201 Patients • NCT03053440Trial Design
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- I do not have active hepatitis B.I have symptoms or conditions due to my lymphoma that require treatment.I have a type of slow-growing non-Hodgkin's lymphoma known as follicular lymphoma.My MZL cancer requires systemic therapy and has been confirmed with a biopsy.I haven't had a major infection or been on IV antibiotics in the last 4 weeks.I have hepatitis B but agree to treatment and monitoring while receiving obinutuzumab.I've had lymphoma treatment but stopped steroids 2 weeks ago and am not allergic to obinutuzumab or ibrutinib.My lymphoma has spread to my brain or spinal cord.I do not have a history of uncontrolled seizures.I have a known bleeding disorder, like von Willebrand's or hemophilia.I do not have viral hepatitis.I've been cancer-free for 5 years, except for certain skin, cervical, breast, prostate, or bladder cancers treated curatively.My condition has not transformed into large B cell disease.I do not have serious heart problems or recent heart attacks.I haven't had chemotherapy for another cancer in the last 2 years.I do not have active or uncontrolled immune-related blood disorders.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I do not need blood transfusions for low platelet counts or have bleeding problems.I do not have an autoimmune disorder needing ongoing immunosuppression.I can follow the study's rules or have someone who can ensure I do.I am a woman who cannot become pregnant or I have a negative pregnancy test.I agree to use effective birth control and a barrier method during and after treatment.My gastric MZL cancer is advanced, affecting areas beyond its origin.I haven't had a stroke or brain bleed in the last 6 months.My condition is a type of follicular lymphoma.I am not pregnant, have tested negative for pregnancy, and will use birth control during and after the treatment.My condition requires treatment based on standard GELF criteria.My condition is marginal zone lymphoma.My disease is at stage II, III, or IV.My cancer cells test positive for CD20.I am able to care for myself and perform daily activities.I have symptoms or complications from lymphoma, including large tumors or spleen enlargement.My skin lymphoma has spread beyond the skin.I have nodal or splenic marginal zone lymphoma and need systemic therapy.My condition is extranodal marginal zone lymphoma.I am currently taking warfarin or similar blood thinners.I have Hepatitis C but my viral load is undetectable.I need treatment with a strong medication that affects liver enzymes.I received a live vaccine at least 28 days before starting treatment.My lymphoma is a type that grows slowly and hasn't been treated yet.I have severe liver problems.I have MZL and need treatment that affects my whole body.My MZL is not in the stomach or skin and needs treatment.My kidneys work well enough, with a creatinine clearance of 30 ml/min or more.My liver functions well and is not in a state of severe failure.I am HIV or HTLV-1 positive.
- Group 1: Treatment (ibrutinib, obinutuzumab)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
What medical conditions has Ibrutinib been shown to improve?
"While waldenstrom macroglobulinemia is the primary reason that Ibrutinib is prescribed, it can also be used to effectively manage refractory follicular lymphoma, chronic lymphocytic leukemia (cll), and lymphoid leukemia."
What is the maximum amount of participants for this experiment?
"Yes, an online search of clinicaltrials.gov will show that the trial is still recruiting patients. The listing was created on February 20th, 2018 and last updated September 29th, 2020. Currently, they are looking for 30 individuals to participate at a single location."
Are there any room for new participants in this research?
"Yes, this is an ongoing clinical trial that was initially posted on February 20th, 2018. The study's most recent update was on September 29th, 2022 and 30 patients are needed at a single location."
Does Ibrutinib have a high potential for patient harm?
"Ibrutinib falls into the Phase 2 category, which suggests that while there is some data affirming its safety, none of the clinical trials conducted thus far have looked at its efficacy."
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