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New treatment option for Acute Myeloid Leukemia
Official title Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT03383575
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as 5 AZC, 5-AC.
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
- This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
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
- Signed, informed consent must be obtained prior to any study specific procedures
- people with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T)...
- people must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result
- (Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other...
- (Arm A only): people with high-risk MDS (i.e. International Prostate Symptom Score [IPSS] intermediate-2 or high-risk; or revised [R]-IPSS high or...
You likely can't join if
- Any prior or coexisting medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's...
- Subject has received a prior targeted IDH2 inhibitor
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study...
- Active uncontrolled infection at study enrollment including known diagnosis of human immunodeficiency virus or chronic active hepatitis B or C...
- Clinically significant gastrointestinal conditions or disorders that may interfere with study drug absorption, including prior gastrectomy
- Patients with known active central nervous system (CNS) disease, including leptomeningeal involvement
See the full eligibility criteria
- Signed, informed consent must be obtained prior to any study specific procedures
- people with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T) (acute myeloid leukemia [AML] with 20-30% blasts and multilineage dysplasia...
- people must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result
- (Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other MDS-directed therapy such as lenalidomide is allowed
- (Arm A only): people with high-risk MDS (i.e. International Prostate Symptom Score [IPSS] intermediate-2 or high-risk; or revised [R]-IPSS high or very-high risk). Patients with intermediate-1 risk by IPSS or...
- (Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Serum bilirubin =\< 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease)
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =\< 3 x the laboratory ULN
- Serum creatinine =\< 2 x the ULN
- Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements
- Resolution of all clinically significant treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to =\< grade 1 prior to the first dose of study treatment
- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a...
- Any prior or coexisting medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
- Subject has received a prior targeted IDH2 inhibitor
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures
- Active uncontrolled infection at study enrollment including known diagnosis of human immunodeficiency virus or chronic active hepatitis B or C infection
- Clinically significant gastrointestinal conditions or disorders that may interfere with study drug absorption, including prior gastrectomy
- Patients with known active central nervous system (CNS) disease, including leptomeningeal involvement
- Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial...
- people with a corrected QT (QTc) \> 480 ms (QTc \> 510 msec for people with a bundle branch block at baseline
- Nursing or pregnant women
- people with known hypersensitivity to study drugs or their excipients
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Cleveland, Ohio, 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 study runs about 3 years 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, 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; Cleveland, Ohio, 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.