BridgeMD
Study aimed at evaluating the efficacy of the combination of the two drugs, Venetoclax and Azacitidine, on the treatment of patients suffering from Acute Myeloid Leukemia with NPM1 mutation.
EU CTIS ID: 2023-510432-36-00
What this study is testing
The primary objective of the trial is to determine the efficacy of venetoclax and azacitidine in preventing morphological relapse in adult NPM1mut AML patients who experience molecular relapse/progression during chemotherapy treatment or subsequent follow-up monitoring.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject must be greater than or equal to 18 years of age
- Female subjects of childbearing potential must have negative results for pregnancy test at screening
- Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from screening through 3 months after the end of treatment.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Subject must have received previous diagnosis of NPM1mut AML with or without concomitant FLT3-TKD or FLT3-ITD
- At screening, subject must have confirmed NPM1 type A, B, or D mutant transcripts
You likely can't join if
- Subject has acute promyelocytic leukemia (APL)
- Creatinine clearance < 30 ml/min
- Subject has a cardiovascular disability status of New York Heart Association Class > 2 a. Class 2 is i. defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity ii. results in fatigue, palpitations, dyspnea, or anginal pain
- Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Post-menopausal women must be amenorrhoic for at least 12 months to be considered of non-child bearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drugs.
- Patients unwilling or unable to comply with the protocol
- Subject has known active CNS involvement with AML
See the full eligibility criteria
Who can join
- Subject must be greater than or equal to 18 years of age
- Female subjects of childbearing potential must have negative results for pregnancy test at screening
- Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from screening through 3 months after the end of treatment.
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Subject must have received previous diagnosis of NPM1mut AML with or without concomitant FLT3-TKD or FLT3-ITD
- At screening, subject must have confirmed NPM1 type A, B, or D mutant transcripts
- Subject must be eligible for alloSCT, according to transplant center policy
- Subject must have undergone at least two cycles of conventional anthracycline- and cytarabine based chemotherapy, achieving first CR (CR1)
- Subject must be in morphological CR1 with bone marrow detectable minimal residual disease (MRD) positivity, defined as qRT-PCR NPM1 transcript = 0.01/100 ABL1 copies and confirmed in two consecutive determinations performed at 2 to 4 weeks’ distance: a. Molecular progression is defined in patients with molecular persistence at low copy number as an increase of MRD copy number = 1 log10 between 2 positive samples. b. Molecular relapse is defined in patients previously tested MRD negative as an increase in MRD copy number = 1 log10 between 2 positive samples
- Subject must have a projected life expectancy of at least 12 weeks.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status < 2
- Subject must have adequate renal and hepatic function per local laboratory reference range as follows: - Aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0X ULN - Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of nonhepatic origin) - Subject must have adequate renal function as demonstrated by a creatinine clearance = 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours’urine collection.
What rules you out
- Subject has acute promyelocytic leukemia (APL)
- Creatinine clearance < 30 ml/min
- Subject has a cardiovascular disability status of New York Heart Association Class > 2 a. Class 2 is i. defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity ii. results in fatigue, palpitations, dyspnea, or anginal pain
- Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Post-menopausal women must be amenorrhoic for at least 12 months to be considered of non-child bearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drugs.
- Patients unwilling or unable to comply with the protocol
- Subject has known active CNS involvement with AML
- Subject has received previous treatment with venetoclax and/or hypomethylating agents
- Subject has undergone alloSCT for AML
- Subject has more than 5% of bone marrow blast cells at screening bone marrow aspirate
- Subject is known to be positive for HIV
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal) b. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
- Cardiac history of CHF requiring treatment or Ejection Fraction = 50% or chronic stable angina;
- DLCO = 65% or FEV1 = 65%;
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.