Clinical trial for Refractory Acute Myeloid Leukemia
Official title Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06177067
What this study is testing
What is Revumenib?
an investigational oral medicine being studied for refractory or relapsed acute myeloid leukemia (AML) and acute leukemia of ambiguous lineage (ALAL). is designed to block the interaction between menin and KMT2A proteins, which can help stop the growth of leukemia cells with certain genetic changes.
Also referred to as SNDX-5613.
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 checks if adding a new drug called revumenib to two other medicines is safe. It also looks for signs that the treatment helps the cancer go away.
- Who it's for
- Children and young adults whose acute myeloid leukemia or related blood cancer has come back or did not respond to previous treatment.
- What's involved
- Participants will receive three drugs: revumenib, azacitidine, and venetoclax. They may also take a medicine to prevent fungal infections.
- Time commitment
- The study duration and specific visit schedule are not listed in the provided text.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed...
- Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), NPM1 mutation or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A...
- Adequate organ function, defined as total bilirubin \< 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients...
- QTcF \< 480 msec (average of triplicate)
- Age ≥ 1 year and ≤ 30 years. The upper age limit may be defined by each institution, but may not exceed 30 years.
You likely can't join if
- Patients who are pregnant or breastfeeding are not eligible.
- Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.
- Patients with uncontrolled infection are not eligible. Patients with infections that are controlled on concurrent anti-microbial agents are eligible.
See the full eligibility criteria
- Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed leukemia, defined as the re-appearance of leukemia after the...
- Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), NPM1 mutation or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A rearrangement (KAT6Ar), or SET::NUP214
- Adequate organ function, defined as total bilirubin \< 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients with known Gilbert's syndrome, total bilirubin \<3 × the ULN) unless...
- QTcF \< 480 msec (average of triplicate)
- Age ≥ 1 year and ≤ 30 years. The upper age limit may be defined by each institution, but may not exceed 30 years.
- Lansky ≥ 60 for patients who are \ 16 years old.
- At least 14 days or 5 half-lives (whichever is longer) must have elapsed since the completion of myelosuppressive therapy, with the exception of low-dose therapy used for cytoreduction according to institutional...
- Patients must have a leukocyte count \<25,000 cells/uL. Low-dose therapy, such as hydroxyurea or cytarabine as described above, to achieve this limit is acceptable.
- For patients who have received prior HCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HCT, and patients should be off calcineurin inhibitors for at least 28 days prior to the...
- Patients must be taking posaconazole or voriconazole, which must be started at least 24 hours prior to the start of therapy.
- Patients of reproductive potential must agree to use effective contraception for the duration of study participation. Patients who meet the criteria listed above are eligible for enrollment and treatment on the trial.
- Patients who are pregnant or breastfeeding are not eligible.
- Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.
- Patients with uncontrolled infection are not eligible. Patients with infections that are controlled on concurrent anti-microbial agents are eligible.
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Fort Worth, 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, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Kansas City, Missouri, United States; New York, New York, United States; Cincinnati, Ohio, United States and 4 more locations. 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.