A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating A… (NCT05285813) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure
Stopped: \<75% participation
United States51 participantsStarted 2022-05-06
Plain-language summary
This is a phase II single-center study to evaluate the safety and effectiveness of vibecotamab, a CD3-CD123 bispecific antibody, in patients with acute myeloid leukemia with persistent or recurrent measurable residual disease and in patients with myelodysplastic syndrome that has not responded to or relapsed after conventional therapy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults ≥18 years of age
. AML MRD cohort only: AML in first or second morphologic remission (defined as complete remission \[CR\], complete remission with incomplete hematologic recovery \[CRi\], or morphologic leukemia-free state \[MLFS\]) who have received a minimum prior therapy with at least 1 course of intensive intermediate to high-cytarabine-based chemotherapy or at least 2 courses of lower-intensity therapy (e.g. hypomethylating agent or low-dose cytarabine-based)
. AML MRD cohort only: Persistent or recurrent MRD positivity detected by MFC at a level of ≥0.1%.
. AML MRD cohort only: For patients who are MRD positive by MFC, residual leukemia must be positive for CD123 expression at a level of at least 20% (as assessed by clinical pathologist)
. MDS post-HMA failure cohort only: MDS that is intermediate, high risk or very high risk by the Revised International Prognostic Scoring System (IPSS) or CMML-1 or CMML-2 who have not responded after at least 4 cycles of azacitidine and/or decitabine or who progressed or relapsed after azacitidine and/or decitabine, regardless of the number of cycles received
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the MRD negativity rate after 4 cycles of vibecotamab in patients with AML with MRD
Timeframe: through study completion, an average of 1 year
2
To determine the response rate (defined as CR + marrow CR [mCR] + partial remission [PR] + hematologic improvement [HI]) after 4 cycles of vibecotamab in patients with MDS after HMA failure
Timeframe: through study completion, an average of 1 year
. MDS post-HMA failure cohort only: Aberrant blasts must be positive for CD123 expression by MFC at a level of at least 20% (as assessed by clinical pathologist)
. Performance status 2 (ECOG Scale).
. Female patients of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after the last dose of vibecotamab and must also refrain from oocyte donation during this time period. Women are considered to be of childbearing potential unless it is documented that they are over the age of 60 OR postmenopausal by history with no menses for 1 year and confirmed by follicle-stimulating hormone (using local reference ranges) OR have a history of hysterectomy and/or bilateral oophorectomy OR have a history of bilateral tubal ligation. Highly effective methods of birth control include hormonal birth control (oral, intravaginal, transdermal, implantable, or intrauterine), intrauterine devices, vasectomized partner, or any double-barrier methods (combination of male condom and spermicide with either cap, diaphragm, or sponge).
Exclusion criteria
. Prior treatment with vibecotamab or anti-CD123-directed therapy.
. Clinically significant organ dysfunction, defined as:
. AST or ALT \>3x the upper limit of normal (ULN)
. Total bilirubin \>1.5x the ULN, unless due to ongoing hemolysis or Gilbert's syndrome
. Creatinine clearance \<30 mL/min
. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
. Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of clinical improvement despite antimicrobial treatment).
. Patients who are expected to be able to proceed with stem cell transplantation within the next 30 days