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Tests treatment safety and results for Acute Myeloid Leukemia
Official title Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
ClinicalTrials.gov ID: NCT05101551
What this study is testing
What is Talazoparib?
Talazoparib is an investigational medicine, given as an once-daily, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Talzenna.
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 is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study.
- 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 up to 21
You may be able to join if
- Aged ≤ 21 years.
- Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia), specified as...
- Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics Inc.
- A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic blasts by flow cytometry (as assessed by Hematologics Inc), AND at...
- Karyotypic abnormality with at least 1 metaphase similar or identical to diagnosis
You likely can't join if
- Patients receiving or planning to receive ANY concurrent cancer therapy, including chemotherapy, radiation therapy, immunotherapy or biologic therapy.
- Patients with down syndrome.
- Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia (JMML).
- Patients with Bone Marrow Failure Syndrome.
- Pregnant people or those unwilling to use an effective method of birth control.
- Female people with infants who do NOT agree to abstain from breastfeeding.
See the full eligibility criteria
- Aged ≤ 21 years.
- Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia), specified as either refractory (persistent leukemia after at least 2 courses of...
- Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics Inc.
- A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of the following:
- Karyotypic abnormality with at least 1 metaphase similar or identical to diagnosis
- FISH abnormality identical to one present at diagnosis
- PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
- Rising MRD \> 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by Hematologics Inc.
- If an adequate bone marrow sample is not obtained, people may be enrolled if there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral blood
- \> 60 days has passed since hematopoietic stem cell transplant.
- Patients who have undergone previous allogeneic stem cell transplantation who are otherwise eligible must also be without evidence of any active graft versus host disease (GVHD), and off calcineurin inhibitors for at...
- A minimum of 14 days has passed since completion of myelosuppressive therapy or gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.
- A minimum of 24 hours has elapsed since the patient has completed any low-dose or non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100 mg/m2).
- Lansky (people ≤ 16 years old) or Karnofsky (people \> 16 years old) score ≥ 50.
- WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea or low-dose cytarabine (up to 100 mg/m2/dose)
- Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
- AST/ALT ≤ 5 x ULN for age
- Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
- Estimated serum creatinine ≥ 60 mL/min/1.73m2
- Patients receiving or planning to receive ANY concurrent cancer therapy, including chemotherapy, radiation therapy, immunotherapy or biologic therapy.
- Patients with down syndrome.
- Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia (JMML).
- Patients with Bone Marrow Failure Syndrome.
- Pregnant people or those unwilling to use an effective method of birth control.
- Female people with infants who do NOT agree to abstain from breastfeeding.
- Inability or unwillingness of legal guardian/representative to give written informed consent.
- Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- Stanford, California, United States
- Cincinnati, Ohio, United States
- Hershey, Pennsylvania, United States
- Memphis, Tennessee, United States
- Salt Lake City, Utah, United States
- Madison, Wisconsin, 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 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, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Duarte, California, United States; Stanford, California, United States; Cincinnati, Ohio, United States; Hershey, Pennsylvania, United States and 3 more location(s). 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.