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New treatment option for Acute Myeloid Leukemia
Official title Ziftomenib Maintenance Post Allo-HCT
ClinicalTrials.gov ID: NCT06440135
What this study is testing
What is Ziftomenib?
Ziftomenib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as KO-539.
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 purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
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
- 18 years or older.
- Pathologically confirmed diagnosis of acute myeloid leukemia (AML).
- Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.
- Complete remission (CR):
- no circulating blasts in peripheral blood and \<5% blasts in bone marrow
You likely can't join if
- History of other malignancy(ies) unless
- the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or
- the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further...
- the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin
- Known diagnosis of active hepatitis B or hepatitis C
- Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic...
See the full eligibility criteria
Who can join
- 18 years or older.
- Pathologically confirmed diagnosis of acute myeloid leukemia (AML).
- Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.
- Complete remission (CR):
- no circulating blasts in peripheral blood and \<5% blasts in bone marrow
- no extramedullary disease
- platelet count ≥100 x 10(9)/L and/or absolute neutrophil count ≥1000/µL
- Complete remission with incomplete count recovery (CRi):
- no circulating blasts in peripheral blood and \<5% blasts in bone marrow
- no extramedullary disease
- platelet count \<100 x 10(9)/L and/or absolute neutrophil count \<1000/µL
- Presence of at least one of the following molecular mutations:
- KMT2A rearrangement
- Eligibility and enrollment will be based on local mutational testing.
- The presence of a KMT2A rearrangement (excluding partial tandem duplication [PTD]) at the time of initial diagnosis or any other time thereafter is sufficient.
- Participants may receive additional treatment for AML between consent and transplant.
- NPM1 mutation
- Eligibility and enrollment will be based on local mutational testing.
- For participants being transplanted in CR1, the presence of a NPM1 mutation at screening is necessary for the purposes of eligibility.
- For participants being transplanted in greater than or equal to CR2, the presence of a NPM1 mutation at the time of consent is not necessary for eligibility and its presence at the time of initial diagnosis or any other...
- Participants may receive additional treatment for AML between consent and transplant.
- Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible.
- Will undergo first allogeneic HCT for their malignancy.
- Transplantation will be performed with the use of conventional myeloablative (MAC) or reduced intensity conditioning (RIC).
- HCT Donor will be one of the following:
- 5/6 or 6/6 (HLA-A, B, DR) matched related donor
- 7/8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level.
- Haploidentical related donor, defined as ≥ 3/6 (HLA-A, B, DR) matched
- ≥ 4/6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least...
- Any non-investigational GVHD prophylaxis regimen is allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Participants must have normal organ and function as defined below:
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN)
- Total bilirubin \< 1.5 x institutional ULN (with the exception of people with a history of Gilbert's syndrome, for which the total bilirubin must be \< 5 x ULN)
- Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
- LVEF must be ≥50%, as measured by MUGA scan or echocardiogram.
- Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing.
- The effects of ziftomenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- History of other malignancy(ies) unless
- the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or
- the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up
- the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin
- Known diagnosis of active hepatitis B or hepatitis C
- Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 50%, as measured by multigated acquisition (MUGA)...
- Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome
- Systemic uncontrolled infection
- Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally
- Uncontrolled hypertension (systolic blood pressure [BP] \> 180 mmHg or diastolic BP \> 100 mmHg)
- QTc interval (i.e., Friderica's correction [QTcF]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome)...
- Uncontrolled intercurrent illness that would limit compliance with study requirements.
- Persons who are pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Columbus, Ohio, United States
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Boston, Massachusetts, United States; Columbus, Ohio, United States. 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.