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Ibrutinib + Rituximab + Chemotherapy for Mantle Cell Lymphoma
Study Summary
This trial is testing ibrutinib, rituximab, and consolidation chemotherapy as a treatment for mantle cell lymphoma in young patients.
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?
Media Library
- I have a serious medical condition.I am HIV positive.I have an active hepatitis B or C infection.I have lymphoma in my brain or spinal cord.I have had severe nerve pain or tingling in the last 2 weeks.I cannot take certain medications or treatments due to adverse reactions.I do not have severe heart issues like recent heart attacks or heart failure.I have not been treated for an infection in the last 14 days.I am 65 years old or younger.My cancer can be measured in two dimensions.I have not had major surgery in the last 4 weeks.I need to take warfarin for blood thinning.My biopsy shows I have mantle cell lymphoma with CD20 positive.I have aggressive MCL with symptoms needing immediate treatment.I have a newly diagnosed condition and have not received any treatment.I have a condition that affects how my body absorbs nutrients.My kidneys are functioning well enough to clear at least 30 mL/min.My cancer is only in my gastrointestinal tract, bone marrow, or spleen.I can take care of myself but cannot do heavy physical work.I have no other cancers, except for certain allowed types.I need treatment with strong CYP3A inhibitors.
- Group 1: Treatment (ibrutinib, rituximab, consolidation 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
Are individuals aged 55 and above eligible for the current research protocol?
"To be part of this clinical trial, potential participants must between 18 and 65 years old. There are 767 trials for minors, and 3246 studies for seniors."
Has the FDA sanctioned Rituximab for therapeutic use?
"The safety of Rituximab was determined to be a 2 due to its Phase 2 trial status, which implies that while there is evidence of its security profile, no data exists attesting to the drug's efficacy."
To what medical ailments is Rituximab most often prescribed?
"Rituximab is regularly used to manage leukemia, but can also be prescribed for synovitis, ophthalmia, sympathetic nerve problems and lung cancers."
Could I theoretically take part in this investigation?
"This medical trial is looking to enrol 131 subjects suffering from pleomorphic variant mantle cell lymphoma and aged between 18-65. The key criteria for application are: documented evidence of CD20 positvity in tissue biopsy, a Mantle Cell International Prognostic Score (MIPI) higher than 3, Ki-67 levels above 30%, risk of organ dysfunction due to the disease, raised LDH concentrations, PB WBC count over 50K and bulky tumours measuring 7 cm or more if there are two or more with diameters exceeding 5cm each."
How many participants can this research effort accommodate?
"At the moment, this trial is not currently seeking enrolment. It was first posted on June 3rd 2015 and last edited August 30th 2022. For those searching for other medical studies, there are 1720 trials with pleomorphic variant mantle cell lymphoma actively recruiting participants and 2033 research programs utilizing Rituximab that require patients."
Is this research initiative still accepting participants?
"The findings on clinicaltrials.gov demonstrate that this research trial is no longer recruiting participants as it was previously posted in June 2015 and last updated in August 2022. Despite the conclusion of recruitment for this particular experiment, there are still 3753 other investigations actively seeking patients at present."
Are there any documented accounts of Rituximab being utilized in prior research?
"Currently, there are 2033 research projects related to Rituximab in progress. Of these initiatives, 436 have reached Phase 3, with the majority located near Ascoli Piceno, Provincia. Globally speaking however, 66825 study sites exist for this particular drug."
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