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8-Chloroadenosine + Venetoclax for Acute Myeloid Leukemia
Study Summary
This trial is testing a new combination therapy of 8-chloroadenosine and venetoclax to see if it is safe and effective in treating patients with acute myeloid leukemia.
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 2021 Phase 1 & 2 trial • 20 Patients • NCT02509546Trial Design
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Who is running the clinical trial?
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- I have no active cancer except possibly skin, bladder, prostate, breast, or cervical cancer that hasn't spread.I have relapsed and am not eligible for a specific stem cell transplant.I am 18 years old or older.I have been diagnosed with acute promyelocytic leukemia.My condition is newly diagnosed acute myeloid leukemia.I cannot swallow pills or have a condition affecting my gut's ability to absorb nutrients.I agree not to donate sperm during and for 90 days after treatment.I have severe heart condition limitations.My heart rhythm problem is stable, or I have controlled atrial fibrillation.I have an active stomach or intestinal ulcer.My leukemia has spread to my brain or spinal cord.I am not using, nor plan to use, any cancer treatments or investigational drugs during the study, except possibly Hydroxyurea.I had a stem cell transplant over 3 months ago, have no active GVHD, and am on low-dose steroids or none.My AML has come back or didn't respond to treatment.I haven't taken strong CYP3A inducers or St. John's Wort in the last 7 days.I am using or will use medication that can affect my heart's electrical cycle.I have not had a heart attack or unstable angina in the last 6 months.I haven't taken specific strong medications in the last 7 days.My cancer did not fully respond after 2 treatments and I can't have a stem cell transplant.My kidneys are working well, as shown by a test.My white blood cell count is low enough to start treatment.I can take care of myself and perform daily activities.My AML cancer has returned after treatment.I meet one of the specific treatment history requirements.I am capable of having children and have not been surgically sterilized.I have a history of fainting, heart disease, or weak heart muscle.I do not have an active fungal infection or bacterial sepsis.I haven't taken P-gp inhibitors in the last 7 days.I am not pregnant or breastfeeding.I am expected to have a stem cell transplant within the next 4 months.I have had surgery or have a condition that might affect how my body absorbs medication.I haven't taken certain strong medications or consumed grapefruit and similar fruits in the last 3 days.My AML came from MDS or a myeloproliferative disorder and treatments like HMA didn't work.
- Group 1: Treatment (8-chloroadenosine, venetoclax)
- 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
To what extent is 8-Chloroadenosine a safe and reliable treatment for individuals?
"The data available for 8-Chloroadenosine's safety and efficacy is limited, thus it was rated a 1 on the Power team scale."
How many participants have enrolled in the research project thus far?
"Affirmative. Clinicaltrials.gov attests that this research study, which was initially posted on July 25th 2022, is currently recruiting participants. Approximately 30 patients are being called for at a single medical centre."
What are the primary goals of this research endeavor?
"This clinical trial will be evaluated over the course of a 28-day cycle. The primary outcome is to measure adverse effects, while secondary objectives include assessing time to response (defined by ELN criteria 2017) using Kaplan and Meier's product-limit method, determining duration of response according to ELN guidelines and employing Kaplan and Meier once again, as well as measuring overall survival with the same methodology."
Are there any vacancies available in this study for participants?
"Affirmative. The information provided on clinicaltrials.gov suggests that this medical trial is actively enrolling participants and was initially posted on July 25th 2022, with its most recent update occurring on August 15th 2022. At present, the study requires 30 individuals to register from a single facility."
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