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Tuspetinib + Venetoclax for Acute Myeloid Leukemia(APTIVATE Trial)
APTIVATE Trial Summary
This trial is testing a new drug, HM43239, for patients with relapsed or refractory acute myeloid leukemia (AML). The goal is to find the safe dose range and to see how well the drug works.
- Acute Myeloid Leukemia
APTIVATE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowAPTIVATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Awards & Highlights
APTIVATE Trial Design
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Who is running the clinical trial?
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- You have severe and ongoing side effects from the transplant that are not related to blood problems.You have leukemia or another disease that has spread to your brain or central nervous system (CNS).You have a type of cancer other than acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is currently active.You have a history of heart problems listed below:
- Heart attack
- Heart failure
- Abnormal heart rhythm
- Heart valve problems
- Blocked blood vessels in the heartYou have experienced severe side effects from a certain type of medication called tyrosine kinase inhibitor.You have severe side effects from previous treatments for AML that are still ongoing and affecting your body, with symptoms and test results to prove it.You have received a type of transplant called hematopoietic stem cell transplant (HSCT).You have a serious condition called graft-versus-host-disease (GVHD) that needs to be treated.You have already tried at least one cycle of treatment, but it did not work for you.You have had a relapse after getting better with a previous treatment.
- Group 1: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax)
- Group 2: Part A Dose Escalation
- Group 3: Part B Dose Exploration
- Group 4: Part C Dose Expansion (tuspetinib as a single agent)
- 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
What other kinds of trials are similar to this one?
"To date, there has only been one ongoing study for HM43239. This trial is being conducted across 3 cities in 2 different countries. The first ever clinical trial involving HM43239 was completed in 2019 by Aptose Biosciences Inc.. That particular study had 218 participants and successfully navigated Phase 1 & 2 of the drug approval process. In the years since 2019, an additional 34 trials have been carried out."
Is this the first time that HM43239 has been used in research?
"The drug HM43239 was first trialled in 2019 at Asan Medical Center. To date, there have been a total of 34 completed studies. Out of these, 1 is an active clinical trial with the majority being conducted in Sacramento, California."
Are we currently enrolling patients for this trial?
"The latest information on clinicaltrials.gov reveals that this trial is ongoing and recruiting patients. The listing was first created on March 11th, 2019 and updated September 13th, 2020."
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