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New treatment option for Acute Myeloid Leukemia
Official title A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT05732103
What this study is testing
What is CTX-712?
CTX-712 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
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 goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML). The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development.
- Phase 2: a mid-size study of how well it works
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
- Age ≥18 years.
- Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion...
- Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for patients in the expansion cohorts.
- Adequate organ function evidenced by the following laboratory values: Creatinine clearance (CL) ≥60 mL/min
- Total serum bilirubin \< 1.5 × upper limit of normal (ULN)
You likely can't join if
- Diagnosis of acute promyelocytic leukemia.
- Isolated extramedullary relapse (phase 2 only).
- Active central nervous system (CNS) leukemia.
- History of other malignancy.
- Any of the following cardiopulmonary abnormalities:
- Myocardial infarction within six months prior to registration.
See the full eligibility criteria
- Age ≥18 years.
- Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion cohorts.
- Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for patients in the expansion cohorts.
- Adequate organ function evidenced by the following laboratory values: Creatinine clearance (CL) ≥60 mL/min
- Total serum bilirubin \< 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase(AST) \< 2.5 × ULN
- White blood cell count at the time of the first dose \<10 k/μL
- Eastern Cooperative Oncology Group performance status ≤2.
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before study treatment initiation and if sexually active, agree to use a highly effective form of contraception throughout...
- Male patients with female partners of childbearing potential must, even if surgically sterilized, agree to practice effective barrier contraception during the entire study treatment period and through four months after...
- Diagnosis of acute promyelocytic leukemia.
- Isolated extramedullary relapse (phase 2 only).
- Active central nervous system (CNS) leukemia.
- History of other malignancy.
- Any of the following cardiopulmonary abnormalities:
- Myocardial infarction within six months prior to registration.
- New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \< 50%.
- A history of familial long QT syndrome.
- Symptomatic atrial or ventricular arrhythmias not controlled by medications.
- QTcF ≥ 470 msec calculated according to institutional guidelines, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor.
- Known moderate to severe and clinically significant chronic obstructive pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home oxygen therapy).
- Pregnancy and/or lactation.
- Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of CTX-712.
- History of allogeneic organ transplantation (excluding cornea).
- History of allogenic hematopoietic stem cell transplantation within 6 months of planned study treatment initiation and/or graft-versus host disease grade ≥ 1 following allogenic hematopoietic stem cell transplantation.
- History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy.
- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness. Infections...
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- Rochester, New York, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, 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 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 Phoenix, Arizona, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States; Rochester, New York, United States; Houston, Texas, United States 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.