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New treatment option for Acute Myeloid Leukemia Refractory
Official title AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05211570
What this study is testing
What is AB8939?
AB8939 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia refractory.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- DOSE ESCALATION STUDY Key
- Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and...
- Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based...
- ECOG performance status ≤ 1
- Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
You likely can't join if
- Patients eligible to a standard of care
- Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
- Patients diagnosed with acute promyelocytic leukemia (M3)
- Patients with clinically active CNS leukemia
- Patients with HSCT within 100 days prior to the first administration of AB8939
- Women who are lactating/breastfeeding or who plan to breastfeed while on study
See the full eligibility criteria
- DOSE ESCALATION STUDY Key
- Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
- Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.
- ECOG performance status ≤ 1
- Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key
- Patients eligible to a standard of care
- Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
- Patients diagnosed with acute promyelocytic leukemia (M3)
- Patients with clinically active CNS leukemia
- Patients with HSCT within 100 days prior to the first administration of AB8939
- Women who are lactating/breastfeeding or who plan to breastfeed while on study
- Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply EXPANSION COHORT STUDY Key Inclusion Criteria:
- Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.
- ECOG performance status ≤ 2
- Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria:
- Patients eligible to a standard of care
- Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
- Patients diagnosed with acute promyelocytic leukemia (M3)
- Patients with clinically active CNS leukemia
- Patients with HSCT within 100 days prior to the first administration of AB8939
- Women who are lactating/breastfeeding or who plan to breastfeed while on study
- Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Marseille, France
- Athens, Greece
- Alicante, Spain
- Cáceres, Spain
- Madrid, Spain
- Pamplona, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Marseille, France; Athens, Greece; Alicante, Spain; Cáceres, Spain; Madrid, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.