Is NCT07059975 recruiting in Houston, TX?

Yes, NCT07059975 is currently recruiting participants at its Houston, TX location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

About This Acute Myeloid Leukemia Study in Houston

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. Patients will enroll on this trial at the end of their first induction cycle. The two cycles to be substituted are: * "Ida-FLA" (idarubicin+fludarabine/cytarabine) as Induction 2 * "VIA" (venetoclax+idarubicin+cytarabine) as Intensification 1 of the HR treatment regimen, and Intensification 2 of the IR treatment backbone. Researchers will evaluate side effects and outcomes for up to three years after enrollment. Participants will also have the opportunity to participate in optional research studies including patient surveys and blood and bone marrow sample testing.

Sponsor: Joanna Yi

Who Can Participate

Inclusion 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 must have 1 of the following at initial diagnosis:

≥ 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 a WBC count of ≥ 5,000/μL with ≥ 20% blasts).

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 patients with therapy-related AML are excluded. Prior Therapy Patients must receive DA10+GO (Cytarabine days 1-10 + Daunorubicin days 1,3,5 \[DA10\] + Gemtuzumab ozogamcin \[GO\]) as prescribed in AAML1831 or the TXCH practice standard for Induction 1. Patients may have received any number of intrathecal treatments and have any CNS status at the time of enrollment. Performance Status Patients must have a performance status corresponding to Karnofsky/Lansky score \>40. (Use Karnofsky for patients ≥16 years of age and Lanksy for patients \<16 years of age.) Organ Function Requirements All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory values used to assess eligibility must be no older than seven (7) days at the start of therapy. Laboratory tests need not be repeated if therapy starts within seven (7) days of obtaining labs to assess eligibility. If a post-enrollment lab value is outside the limits of eligibility, or laboratory values are \> seven (7) days old, then the following laboratory evaluations must be re-checked within 48 hours prior to initiating therapy: CBC with differential, bilirubin, ALT (SGPT) and serum creatinine. If the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy. Adequate renal function defined as: • 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 following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF ≥ 50%, the patient is eligible to enroll. Informed Consent All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

\- 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT07059975) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Houston, TX

If you're searching for acute myeloid leukemia treatment options in Houston, TX, this clinical trial (NCT07059975) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

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