BridgeMD
New treatment option for Myelodysplastic Syndromes
Official title Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
ClinicalTrials.gov ID: NCT05184842
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for myelodysplastic syndromes.
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
- Myeloid malignancies which include AML (acute myeloid leukemia) and MDS (myelodysplatic syndrome) are cancers of the bone marrow which lead to bone marrow failure. The bone marrow is the place or factory in the body where components of blood such as red cells, platelets and white cells are made.
- 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
- Patient must have a diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or myelodysplastic/myeloproliferative neoplasms...
- Indication for therapy with potential sensitivity to hypomethylating agents (HMA) therapy, defined as prior published evidence of response to HMA
- Patients must be 18 years of age or older
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3
- Patients must have adequate end organ function defined as.
You likely can't join if
- Acute promyelocytic leukemia (APL)
- Core binding factor AML who are candidates for chemotherapy
- Prior Treatment with azacitidine, decitabine or venetoclax
- No other disease directed therapy, save for hydroxyurea, including experimental or investigational drug therapy for 14 days prior to study entry
- Currently pregnant or breast-feeding. Females of childbearing potential (FOCBP) must have negative serum pregnancy test within 72 hours from...
- Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
See the full eligibility criteria
- Patient must have a diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN) with a histopathologic diagnosis confirmed by hematopathology review
- Indication for therapy with potential sensitivity to hypomethylating agents (HMA) therapy, defined as prior published evidence of response to HMA
- Patients must be 18 years of age or older
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3
- Patients must have adequate end organ function defined as.
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) \< 4× the upper limit of normal (ULN)
- Bilirubin ≤ 2× the ULN (upper limit of normal). If elevated bilirubin is due to impaired conjugation (e.g., Gilbert's disease or concomitant medication) or disease related hemolysis, then direct bilirubin ≤ 1.5× the ULN
- As decitabine and venetoclax have little renal metabolism, and have proven safety even in dialysis patients, renal function with a creatinine clearance ≥30 mL/min or on dialysis is allowed
- people must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures.
- Acute promyelocytic leukemia (APL)
- Core binding factor AML who are candidates for chemotherapy
- Prior Treatment with azacitidine, decitabine or venetoclax
- No other disease directed therapy, save for hydroxyurea, including experimental or investigational drug therapy for 14 days prior to study entry
- Currently pregnant or breast-feeding. Females of childbearing potential (FOCBP) must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or...
- Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
- Ongoing or active infection. As patients with myeloid malignancies are prone to infections, if patients are actively being treated with appropriate antibiotics or antifungal therapy with clinical evidence of infection...
- Uncontrolled concurrent malignancy
- Congestive heart failure of xNew York Heart Association (NYHA) class III/IV. Patients with compensated heart failure are permitted
- Unstable angina pectoris
- New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted
- Decompensated liver cirrhosis (Child-Pugh score ≥12 or a Model for Enst-Stage Liver Disease (MELD) score ≥21
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the patient or impair the assessment of study results
- Women of Child-Bearing Potential (WOCBP) and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the...
- Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last...
- Patients with uncontrolled active HIV infection, as this will further increase the risk for opportunistic infections. However, patients with HIV with undetectable viral load by polymerase chain reaction (PCR), without...
- Known allergy or hypersensitivity to any component of decitabine or venetoclax formulations
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- The Bronx, New York, United States
- White Plains, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Sacramento, California, United States; The Bronx, New York, United States; White Plains, New York, 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.