Your session is about to expire
← Back to Search
Tuspetinib 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.
APTIVATE Trial Eligibility Criteria
Inclusion Criteria
You may 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.APTIVATE Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have had a stem cell transplant.My leukemia is BCR-ABL positive.I am surgically sterile or had a hysterectomy at least one month ago.My kidney function, measured by creatinine or eGFR, is within the required range.I have significant heart rhythm issues as shown on an ECG.I have not had a donor lymphocyte infusion within the last 30 days or during the first two treatment cycles.I cannot or will not stop taking medications that may affect my heart's rhythm.My leukemia is confirmed as AML according to WHO criteria.I will not donate eggs during and for 3 months after the study.I do not have any active infections, including COVID-19.I have severe heart failure or had it, but my heart's pumping ability is now okay.My cancer has spread to my brain or spinal cord.I had a stem cell transplant within the last 2 months.I received radiation therapy less than 4 weeks ago.I can take pills and am expected to live for at least 3 more months.I have a condition or family history that increases my risk of heart rhythm problems.My partner and I are using effective birth control during and 90 days after the study.I have not had major surgery in the last 4 weeks.I am being treated for a serious condition where my transplant is attacking my body.My condition worsened after initially responding to treatment.I have waited the required time after my last cancer treatment before starting a new one.I agree not to donate sperm from the start of the study until 90 days after the last dose of the study drug.My condition did not improve after at least one treatment cycle.I have been diagnosed with acute promyelocytic leukemia.I have a cancer diagnosis that is not AML or MDS.I am not breastfeeding and will not for 90 days after the last study drug.I have lasting side effects from previous AML treatment that still affect me.I am a woman who is not pregnant, breastfeeding, and I am using birth control.I can take care of myself and perform daily activities.I have an active hepatitis B or C infection, or another liver condition.I have lasting side effects from a transplant that affect my daily life.I have a history of heart problems.I have a blood clotting disorder known as DIC.I have not had a menstrual period for at least 1 year.I had a severe reaction to a cancer drug targeting enzymes.
- 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."
Share this study with friends
Copy Link
Messenger