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New treatment option for Acute Myeloid Leukemia
Official title UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML
ClinicalTrials.gov ID: NCT07059975
What this study is testing
What is Idarubicin Hydrochloride?
Idarubicin Hydrochloride is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
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 research study investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients with newly diagnosed AML at intermediate-risk (IR) and high-risk (HR) of relapse. The goal is to achieve similar or better survival with chemotherapy cycles that are intensive but less likely to cause long-term complications.
- Phase 1: an early, usually small safety study
- 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 1 to 30
You may be able to join if
- \- Age Patients ≥ 1 months old to ≤ 30 years old are eligible Patients must be diagnosed with AML or myeloid sarcoma according to the 2022 WHO...
- ≥ 20% bone marrow blasts
- In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow...
- \< 20% bone marrow blasts with one or more of the genetic abnormalities below:
- t(8;21)(q22;q22.1) RUNX1::RUNX1T1
You likely can't join if
- \- Patients with the following constitutional conditions are not eligible:
- Fanconi anemia
- Schwachman Diamond Syndrome
- Telomere Disorders
- Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
- Germline predispositions known, or suspected by the treating physician, to increase risk of toxicity with AML therapy
See the full eligibility criteria
- \- Age Patients ≥ 1 months old to ≤ 30 years old are eligible Patients must be diagnosed with AML or myeloid sarcoma according to the 2022 WHO classification with or without extramedullary disease. Patients with AML...
- ≥ 20% bone marrow blasts
- In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy.
- \< 20% bone marrow blasts with one or more of the genetic abnormalities below:
- t(8;21)(q22;q22.1) RUNX1::RUNX1T1
- inv(16)(p13.1q22) or t(16;16)(p13.1;q22) CBFB::MYH11
- Translocation involving 11q23.3 KMT2A rearrangement
- t(6;9)(p23;q34.1) DEK::NUP214
- inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2) MECOM rearrangement
- Megakaryoblastic with t(1;22)(p13.3;q13.3) RBM15::MRTFA
- Mutated NPM1
- t(5;11)(q35.3;p15.5) NUP98::NSD1
- inv(16)(p13.3q24.3) CBFA2T3::GLIS2
- t(11;12)(p15.5;p13.5) NUP98::KDM5A
- A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (i.e., a WBC count ≥ 10,000/μL with ≥ 10% blasts or...
- Biopsy-proven myeloid sarcoma with or without bone marrow involvement. Note: patients with newly diagnosed AML, myelodysplasia-related (that are not from conditions listed in protocol section 4.2.1) ARE eligible while...
- A creatinine clearance or GFR ≥ 60 ml/min/1.73m2 Adequate liver function defined as:
- A direct bilirubin \< 2 mg/dL
- ALT \<5x ULN or 225 U/L, with the ULN being 45 U/L for the purpose of this study. Adequate coagulation defined as:
- INR ≤ 1.5 Adequate cardiac function defined as:
- Ejection fraction (EF) ≥ 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) ≥ 24%, within 14 days prior to planned start of Induction 2 therapy.
- For patients with cardiac dysfunction (EF \< 50% or SF \<24% if EF is unavailable) prior to enrollment, if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction...
- \- Patients with the following constitutional conditions are not eligible:
- Fanconi anemia
- Schwachman Diamond Syndrome
- Telomere Disorders
- Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
- Germline predispositions known, or suspected by the treating physician, to increase risk of toxicity with AML therapy
- Therapy-related AML Patients with any of the following oncologic diagnoses are not eligible:
- Any concurrent malignancy
- Juvenile myelomonocytic leukemia
- Philadelphia chromosome positive AML
- Mixed phenotype acute leukemia
- Acute promyelocytic leukemia
- AML with FLT3 internal tandem duplication (FLT3-ITD) Pregnancy and Breastfeeding
- Female patients who are pregnant may not participate. A pregnancy test is required for female patients of childbearing potential.
- Lactating females who plan to breastfeed their infants are not eligible.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 1 month to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.