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AZD4573 for Blood Cancers
Study Summary
This trial is testing a new cancer drug, given in combination with other anti-cancer agents, to people with cancer that has come back or did not respond to other treatments.
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 2020 Phase 2 trial • 177 Patients • NCT04346199Trial Design
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- I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.I am 18 years old or older.My blood counts are within normal ranges.My diagnosis was confirmed through a biopsy and detailed lab tests.I can take care of myself but might not be able to do heavy physical work.You have had a severe allergic or anaphylactic reaction to BH3 mimetics in the past or you are allergic to any of the ingredients in the study treatment.My organs are working well.I have tried at least one treatment for my current illness without success and cannot be treated with the intent to cure.My tumor tissue can be sent to AstraZeneca for testing.I am willing to have an optional tumor biopsy if my cancer progresses.I have a heart condition or take medication that affects my heart's rhythm.I need medication for stomach acid and can switch to other types if needed.I have been diagnosed with HIV.I need medication that strongly affects liver enzymes.I have relapsed or refractory DLBCL or MZL and a clinical trial is my best treatment option.I haven't had lymphoma treatment or radiation in the last 14 days.I am on blood thinners like warfarin.I had cancer before, but it was treated, and I've been cancer-free for over a year.I am on blood thinners, but not on high-dose new oral ones or short-acting heparins.I do not have any severe illnesses or infections that are not under control.My disease has come back or worsened after treatment.I have relapsed or refractory DLBCL and a recent biopsy.I've had at least one treatment for my current illness and a clinical trial is now considered the best next step.My cancer can be seen on scans and involves lymph nodes or tissues.I haven't had blood transfusions or growth factor support in the last 2 weeks.My mantle cell lymphoma has returned or resisted treatment, and a clinical trial is considered my best next treatment option.I am currently being treated for adrenal gland insufficiency or pancreatitis.I have relapsed or refractory DLBCL or MZL and can provide a recent or archival tumor sample.I have tried at least two treatments for my current illness without success and cannot be cured with available treatments.My myeloma does not produce detectable levels of M protein.I have or had brain lymphoma, leptomeningeal disease, or spinal cord compression.I don't have lasting side effects from previous treatments, except for possible hair loss.I have not had major heart or stroke issues in the last 6 months.I have severe stomach or bowel problems that affect how I digest food.My cancer can be seen on scans and involves lymph nodes or tissues.I am currently taking both antiplatelet and anticoagulant medications.I have relapsed or refractory mantle cell lymphoma.
- Group 1: Module 2: Part A and Part B
- Group 2: Module 1: Part A and Part B
- 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
Will this research be beneficial for octogenarians?
"According to the age requirements set out in the inclusion criteria, individuals must be aged 18 or older but no more than 130 years old."
Are there any available vacancies for people who want to participate in this clinical trial?
"Yes, this trial is still enrolling patients as of today. According to the listing on clinicaltrials.gov, the first posting was on February 17th, 2021 and the most recent update was November 8th, 2022."
How do I sign up for the clinical trial?
"A total of 117 people will be enrolled in this trial for hematologic neoplasms. The patients must meet the following criteria: Be 18 years of age or older, have an ECOG performance status of 2 or lower, have received prior lines of therapy that are no longer effective and clinical study is the best option for next treatment based on response and/or tolerability, have active disease that requires treatment and is refractory or relapsed defined as: Disease progression after previous line(s) of therapy or disease that did not respond to the prior treatment regimen, adequate haematological function, adequate organ function at screening,"
What are the main goals that researchers hope to achieve with this trial?
"According to the clinical trial sponsor, Parexel, the primary outcome of this study will be measured over a From Screening (Day -30 to Day -1) until disease progression or survival until death (approximately 6 months) time frame. This outcome is defined as the number of participants with serious and non-serious adverse events. Additionally, this study will evaluate secondary outcomes including plasma PK (AUC0-t) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination; plasma PK (AUClast) of AZD"
Is this the first time that AZD4573 has been used in a research setting?
"The first clinical trial for AZD4573 was completed in 2014. To date, a total of 25 trials have been completed. Currently, there are 76 active trials taking place with many of them located in Columbus, Ohio."
What are the conditions that treatment with AZD4573 typically improves?
"AZD4573 is an effective medication for mantle cell lymphoma (mcl), small lymphocytic lymphoma, and chronic lymphocytic leukemia (cll) patients."
Are there different research facilities participating in this study across America?
"Currently, this clinical trial is taking place in 10 different locations. While the primary sites are in Columbus, Montreal and Toronto, there are also options in other cities to help minimize travel for enrolled patients."
Has this research been undertaken before?
"There are 76 ongoing clinical trials for AZD4573 in 47 different countries. The first trial began in 2014 and was sponsored by Acerta Pharma BV. That study completed its Phase 1 & 2 approval stages with the help of 306 participants. Since then, 25 more trials have concluded."
How many people are participating in this clinical trial at most?
"That is correct, the online clinicaltrials.gov registry reveals that this particular study is still looking for participants. Originally appearing on February 17th, 2021, with the most recent update being on November 8th, 2022; this trial is aiming to enroll 117 individuals across 10 different sites."
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