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A study to evaluate the safety and efficacy of mebendazole in combination with low-dose Ara-C in elderly patients with relapsed/refractory acute myeloid leukemia (MAIL)
EU CTIS ID: 2024-518363-36-00
What this study is testing
Phase I: Studying the safety of the combination of low-dose Ara-C and mebendazole in elderly patients ≥ 70 years with relapsed/ refractory AML Establishing a safe and biologically relevant dose of mebendazole in combination with low dose Ara-C Phase II: Determination of the combined rate of complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) within three months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3)
- Relapsed/refractory disease after standard therapy
- Blast concentration in peripheral blood of > 1000/μl
- Men and women aged >70 years, ineligible for intensive treatment (standard dose)
- Ability to swallow and retain oral medication, no known malabsorption syndrome, adequate organ function
- Ability to understand and provide signed informed consent
You likely can't join if
- Persistence of toxicity of prior chemotherapy above grade 1
- Prior treatment with low dose Ara-C
- Treatment with any investigational agents within a clinical trial in the last four weeks
- Central nervous system (CNS) disease
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
- Intolerance against components of mebendazole or cytarabine formulations (especially E110)
See the full eligibility criteria
- Cytological or histological diagnosis of AML with the exception of promyelocytic leukemia (AML M3)
- Relapsed/refractory disease after standard therapy
- Blast concentration in peripheral blood of > 1000/μl
- Men and women aged >70 years, ineligible for intensive treatment (standard dose)
- Ability to swallow and retain oral medication, no known malabsorption syndrome, adequate organ function
- Ability to understand and provide signed informed consent
- Persistence of toxicity of prior chemotherapy above grade 1
- Prior treatment with low dose Ara-C
- Treatment with any investigational agents within a clinical trial in the last four weeks
- Central nervous system (CNS) disease
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
- Intolerance against components of mebendazole or cytarabine formulations (especially E110)
- Acute or chronic liver diseases with elevated liver enzymes above grade 1
The study team makes the final eligibility decision.
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, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.