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BTX-1188 for Non-Hodgkin's Lymphoma
Study Summary
This trial is testing a new drug for safety, side effects, and how well it works in people with advanced cancer.
- Non-Hodgkin's Lymphoma
- Acute Myeloid Leukemia
- Solid Tumors
Timeline
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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- You have experienced side effects from previous cancer treatments that have not improved or are still causing moderate or severe problems, except for hair loss or mild thyroid issues caused by immunotherapy.You have a serious heart condition that could affect your participation in the study.You have severe complications from leukemia that are immediately life-threatening, such as uncontrolled bleeding, severe pneumonia, or a condition called disseminated intravascular coagulation.You have a history of serious brain or nervous system problems caused by medications.Part A: You have a type of leukemia called AML that has come back or is not responding to treatment. You have tried all the standard treatments that are usually effective, but they didn't work for you.
Part B: You have a type of cancer called B cell NHL or a type of solid tumor that has spread to other parts of your body. It is either not responding to any standard treatments, or you cannot tolerate those treatments. There is no other known treatment available that can cure or control your cancer.
- Group 1: BTX-1188 Dose Cohort 6
- Group 2: BTX-1188 Dose Cohort 1
- Group 3: BTX-1188 Dose Cohort 3
- Group 4: BTX-1188 Dose Cohort 2
- Group 5: BTX-1188 Dose Cohort 4
- Group 6: BTX-1188 Dose Cohort 5
- Group 7: BTX-1188 Dose Cohort 7
- 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 there multiple locations in Canada providing this clinical research?
"Prospective participants may be enrolled in this clinical trial at The Christ Hospital in Cincinnati, City of Hope Medical Center in Duarte, M.D Anderson Cancer Centre in Houston or one of the other 4 sites currently recruiting patients."
Has BTX-1188 been certified by the FDA?
"BTX-1188's safety is still in the early stages of clinical trials, so it earned a score of 1 according to our team at Power. This evaluation accounts for limited data supporting efficacy and safety."
How many participants are currently partaking in this research?
"This clinical study needs 168 volunteers with the required qualifications to take part. Potential participants may come from The Christ Hospital in Cincinnati, Ohio or City of Hope Medical Center in Duarte, California."
Are there still enrolment opportunities available for this trial?
"This trial, which was published on January 24th 2022 and last amended September 8th 2022, is actively accepting new participants as per the data hosted by clinicaltrials.gov."
What aims does this medical trial hope to accomplish?
"The primary objective of this trial, which will occur after Cycle 1 (each cycle is 28 days), is to assess the emergence of adverse events in relation to BTX-1188 consumption among patients suffering from advanced malignancies. Secondary outcomes include measuring area under the plasma concentration curve, peak plasma concentrations and progression free survival time."
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