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New treatment option for Acute Myeloid Leukemia
Official title A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
ClinicalTrials.gov ID: NCT06284486
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ABT-199, GDC-0199.
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
- To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML.
- 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 12 and older
You may be able to join if
- Age ≥ 12 years with weight ≥ 45Kg.
- ECOG performance status of ≤ 2. (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \<18 years); Lansky Performance Score...
- Leukemia status:
- Known history of NPM1mt, or KMT2Ar, or NUP98r AML.
- Bone marrow assessment showing no leukemia by morphology (blasts \<5%) in first remission following high intensity chemotherapy or at least 2 cycles...
You likely can't join if
- Prior treatment with a menin inhibitor.
- Participants who are expected to receive standard therapy (either intensive or hypomethylating agent and venetoclax) with continued side effects and...
- Participants who are expected to be able to proceed with stem cell transplantation within the next 30 days.
- Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at...
- The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal...
- Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
See the full eligibility criteria
- Age ≥ 12 years with weight ≥ 45Kg.
- ECOG performance status of ≤ 2. (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \<18 years); Lansky Performance Score of ≥50 (if aged \<16 years).
- Leukemia status:
- Known history of NPM1mt, or KMT2Ar, or NUP98r AML.
- Bone marrow assessment showing no leukemia by morphology (blasts \<5%) in first remission following high intensity chemotherapy or at least 2 cycles of low intensity therapy (e.g. hypomethylating agent or low-dose...
- No clinically active extramedullary disease.
- Baseline ejection fraction must be \> 40%.
- Adequate hepatic function (direct bilirubin \< 1.5x upper limit of normal (ULN) unless increase is due leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement, in which case...
- Adequate renal function with an estimated glomerular filtration rate ≥ 60 mL/min based on local institutional practice for age-appropriate determination.
- Able to swallow pills.
- Participants or parent/guardian is willing and able to provide informed consent. Interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an...
- Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an...
- Prior treatment with a menin inhibitor.
- Participants who are expected to receive standard therapy (either intensive or hypomethylating agent and venetoclax) with continued side effects and benefit.
- Participants who are expected to be able to proceed with stem cell transplantation within the next 30 days.
- Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
- The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of...
- Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
- Participants with a concurrent active malignancy under treatment.
- Known active hepatitis B (HBV) or Hepatitis C (HCV) or HIV infection.
- Female people who are pregnant or breast-feeding.
- Participant has an active uncontrolled infection.
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening...
- QTc \>450 msec for males and QTc \>470 msec for females using the Fridericia Formula.
- History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participants's participation for the full...
- Clinically active central nervous system (CNS) leukemia.
- Participants on immunosuppressive therapy post-HSCT at the time of screening (must be off all systemic immunosuppression therapy for at least 2 weeks and calcineurin inhibitors for at least 4 weeks). The use of topical...
- Participants with Grade \> 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Houston, Texas, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Boston, Massachusetts, United States; New York, New York, United States; Houston, Texas, 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.