Trial comparing treatments for Acute Myeloid Leukemia
Official title 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)
ClinicalTrials.gov ID: NCT05401097
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, 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 study aims to find out if it is better to start with a targeted pill or a combination of a pill and an injection for this type of leukemia.
- Who it's for
- The study is looking for older adults who have newly diagnosed acute myeloid leukemia with a specific gene change and cannot tolerate strong chemotherapy.
- What's involved
- Participants will receive either a targeted pill first or a combination of a pill and an injection first, followed by the other treatment.
- Time commitment
- The study involves regular visits to the clinic for blood tests and to receive the assigned medications.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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.
- 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.
- 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...
- Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures and study restrictions
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Dallas, 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, but 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?
This study is enrolling now at Aurora, Colorado, United States; Chapel Hill, North Carolina, United States; Columbus, Ohio, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.