IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)
Randomized, Sequential, Open-Label Study to Evaluate the Efficacy of IDH Targeted/Non- Targeted Versus Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To perform minimal residual disease (MRD) monitoring via liquid biopsy via our custom-designed 30-gene mutation ArcherPlex panel to monitor clonal dynamics during both sequential treatment arms."
- "After completion of the study treatment, patients are followed up at 30 days and then every 3 months for 5 years from registration, until death, or withdrawal of consent from study assessments and all further follow-up."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) inhibitors. It works by slowing or stopping the growth of cancer cells. Enasidenib is in a class of medications called an IDH2 inhibitor. It also works by slowing or stopping the growth of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. This study may help researchers determine which treatment order is best for older patients with IDH mutated acute myeloid leukemia: 1) ivosidenib or enasidenib followed by azacitidine plus venetoclax; or 2) azacitidine plus venetoclax followed by ivosidenib or enasidenib.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Patients with newly diagnosed IDH1 or IDH2 mutated AML * Not a candidate for or refuses intensive induction therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Creatinine clearance \> 40 ml/min * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \< 5 x upper limit of normal * Total bilirubin \< 1.5 x upper limit of normal (except for patients with Gilbert's disease) * At the time of Venetoclax initiation, white blood cells (WBC) needs to be \< 25 × 103 microliter: Hydroxyurea can be used to achieve that level. * For female patients of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 6 months following the last dose of either study drug. A serum pregnancy test will be done at screening. A serum or urine pregnancy test will be done on Day 1 of each cycle for women of childbearing potential. If the urine pregnancy test is positive, a serum pregnancy test must be performed per institutional standards. The following methods are acceptable methods of contraception for the purpose of this study: * Highly Effective Contraception Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (Clinical Trials Facilitation Group 2014): * Combined (estrogen and progestin containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). * Progestin-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). * Intrauterine device. * Intrauterine hormone-releasing system. * Bilateral tubal occlusion. * Vasectomized partner, provided that partner is the sole sexual partner of the female study participant and that the vasectomized partner has received medical assessment of the surgical success. * Sexual abstinence- only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. * Acceptable Birth Control Methods that are not Highly Effective Contraception Acceptable birth control methods that result in a failure rate of more than 1% per year: * Progestin-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action. * Male or female condom with or without spermicide. * Cap, diaphragm, or sponge with spermicide. A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) are also acceptable, but not highly effective, birth control methods. * The following methods are NOT acceptable methods of contraception for the purpose of this study: * Periodic abstinence (calendar, symptothermal, postovulation methods). * Withdrawal (coitus interruptus). * Spermicides only. * Lactational amenorrhea method. * Combination of male and female condom * For male patients of childbearing potential having intercourse with females of childbearing potential, the willingness to abstain from heterosexual intercourse or use a protocol recommended method of contraception from the screening visit throughout the study treatment period and for 3 months following the last dose of either study drug. Males must also refrain from sperm donation from the screening visit throughout the study treatment period and for 3 months following the last dose of either dose of study drug * Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures and study restrictions Exclusion Criteria: * Patients with acute promyelocytic leukemia * Known active central nervous system involvement of leukemia * Any active malignancy requiring therapy, that would interfere with the interpretation of study endpoints. * Evidence of ongoing uncontrolled systemic bacterial, fungal or viral infection at the time of start of study treatment * Uncontrolled infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV) * Pregnancy or breast feeding * Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment * Inability to tolerate oral medications including symptomatic disease significantly affecting gastrointestinal function such as inflammatory bowel disease or resection of stomach or small bowel
Study sites (4)
CO
- University of Colorado · Aurora, CO 80205Derek Schatz · Study contact · 303-724-9562 · derek.schatz@cuanschutz.eduMathew Angelos, MD, PhD · Principal investigatorMore trials in Aurora
NC
- UNC Hospitals, University of North Carolina at Chapel Hill · Chapel Hill, NC 27514Study Coordinator · Study contact · 919-966-4432 · cancerclinicaltrials@med.unc.eduJoshua Zeidner, MD · Principal investigatorMore trials in Chapel Hill
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Molly Brandenburg · Study contact · 614-685-9573 · molly.brandenburg@osumc.eduAlice S. Mims, MD · Principal investigatorMore trials in Columbus
TX
- UT Southwestern Medical Center at Dallas · Dallas, TX 75235Donglan Xia, RN, PhD · Study contact · 469-852-0680 · Donglan.Xia@utsouthwestern.eduYazan Madanat, MD · Principal investigatorMore trials in Dallas