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BGB-11417 +/− Zanubrutinib for B-Cell Lymphoma
Study Summary
This trial is testing a new cancer drug, BGB-11417, to see if it is safe and effective when used alone or in combination with another cancer drug, zanubrutinib.
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 been diagnosed with non-Hodgkin lymphoma.My organs are working well.My Waldenström's macroglobulinemia has returned or didn't respond to my first treatment.My mantle cell lymphoma has returned or didn't respond to at least one treatment.My DLBCL cancer returned or didn't respond after 2 treatments and I can't have a stem cell transplant.I have been diagnosed with CLL or SLL.I have a lymph node larger than 1.5 cm or an extranodal lesion larger than 1.0 cm.I have or am suspected to have a specific blood cancer type.My condition either hasn't been treated yet or didn't respond to at least one prior treatment.My slow-growing B-cell lymphoma has become more aggressive, but it did not start as CLL or SLL.I have CLL with a lymph node larger than 1.5 cm or detectable cancer cells in my blood.My pancreas is working well.My CLL/SLL diagnosis meets international standards.I can take care of myself and am up and about more than half of my waking hours.I have been treated with a Bcl-2 inhibitor for at least 2 months or my condition worsened on it.My lymphoma/leukemia has spread to my brain or spinal cord.My follicular lymphoma has returned or didn't respond after at least one treatment.My marginal zone lymphoma has returned or didn't respond to treatment and needs more therapy.
- 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.
- Group 1: : BGB-11417 + Zanubrutinib Combination Therapy Dose Escalation: Part 5
- Group 2: BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion: Part 6
- Group 3: BGB-11417 Monotherapy Dose Finding: Part 1
- Group 4: BGB-11417 Monotherapy Expansion Cohorts: Part 2
- Group 5: BGB-11417 + Zanubrutinib Combination Therapy Dose Finding: Part 3
- Group 6: BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion: Part 4
Frequently Asked Questions
To what extent can BGB-11417 pose a hazard to humans?
"This compound's safety profile is still relatively unproven, warranting a score of 1. BGB-11417 has only been tested in Phase 1 trials, which means there are limited data to back up its purported efficacy and safety."
Is enrollment for this research still open to participants?
"Per the clinicaltrials.gov records, this research is actively seeking volunteers; it was initially published on March 24th 2020 and its details have been updated most recently on July 6th 2022."
Has prior research been conducted on BGB-11417?
"Currently, 137 trials of BGB-11417 are being conducted with 25 in the third phase. While most studies involving this medication are taking place in Nanning, Guangxi there is a total of 3276 sites running related clinical tests."
Is this medical study a pioneering endeavor?
"Currently, 137 trials for BGB-11417 are in progress across 611 municipalities and 49 nations. MEI Pharma, Inc. conducted the inaugural trial of this medication back in 2016 with 177 patients as part of its Phase 1 evaluation process; since then, 30 studies have been concluded successfully."
What is the current number of participants in this clinical research?
"Indeed, clinicaltrials.gov indicates that the current search for participants is ongoing. This medical research was originally posted on March 24th 2020 with its last edit taking place on July 6th 2022. With 8 sites in operation, 418 patients must still be recruited to participate."
To what medical issues is BGB-11417 typically applied?
"BGB-11417 is a viable therapy for waldenstrom's macroglobulinemia, relapsed marginal zone lymphoma and select types of lymphoma."
How many separate sites are managing this research endeavor?
"This medical study is currently being conducted in a total of 8 different sites, including Seattle, Houston and Stanford. To reduce the burden of travelling to participate, it may be beneficial for potential candidates to select the closest location available."
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