Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
NCT ID: NCT05101551
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
34 participants
INTERVENTIONAL
2023-02-23
2026-03-31
Brief Summary
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This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Talazoparib with topotecan and gemcitabine
Talazoparib will be administered orally on Days 1 to 5 concurrently with topotecan and a single dose of gemcitabine on Day 1 of 28 day cycle for 1 or 2 cycles. Subjects on dose level 5 will receive an additional 5 day treatment course of talazoparib on days 15-19.
Talazoparib
Talazoparib will be administered in escalating doses based on current dose level.
* Dose Level 1: 400 µg/m2/dose once daily
* Dose Level 2: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5
* Dose Level 3: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5
* Dose Level 4: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5
* Dose Level 5: 600 ug/m2/dose BID on Day 1, then daily on Days 2 to 5 and 15 to19
Topotecan
Administered IV route on Days 1 to 5
* Dose Level -2: 1 mg/m2/dose once daily by IV days 1 to 5
* Dose Level -1: 2 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 1: 2 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 2: 2 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 3: 3 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 4: 4 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 5: 4 mg/m2/dose once daily by IV days 1 to 5
Gemcitabine
Single dose (IV) of gemcitabine on Day 1 of each 28 day cycle for 1 cycle.
* Dose Level -2: 600 mg/m2/dose once daily by IV days 1
* Dose Level -1: 600 mg/m2/dose once daily by IV days 1
* Dose Level 1: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 2: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 3: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 4: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 5: 1200 mg/m2/dose once daily by IV days 1
Interventions
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Talazoparib
Talazoparib will be administered in escalating doses based on current dose level.
* Dose Level 1: 400 µg/m2/dose once daily
* Dose Level 2: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5
* Dose Level 3: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5
* Dose Level 4: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5
* Dose Level 5: 600 ug/m2/dose BID on Day 1, then daily on Days 2 to 5 and 15 to19
Topotecan
Administered IV route on Days 1 to 5
* Dose Level -2: 1 mg/m2/dose once daily by IV days 1 to 5
* Dose Level -1: 2 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 1: 2 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 2: 2 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 3: 3 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 4: 4 mg/m2/dose once daily by IV days 1 to 5
* Dose Level 5: 4 mg/m2/dose once daily by IV days 1 to 5
Gemcitabine
Single dose (IV) of gemcitabine on Day 1 of each 28 day cycle for 1 cycle.
* Dose Level -2: 600 mg/m2/dose once daily by IV days 1
* Dose Level -1: 600 mg/m2/dose once daily by IV days 1
* Dose Level 1: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 2: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 3: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 4: 1200 mg/m2/dose once daily by IV days 1
* Dose Level 5: 1200 mg/m2/dose once daily by IV days 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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 induction chemotherapy) or relapsed, and further defined as any one of the criteria below:
1. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics Inc.
2. 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
3. Rising MRD \> 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by Hematologics Inc.
4. If an adequate bone marrow sample is not obtained, subjects may be enrolled if there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral blood
3. \> 60 days has passed since hematopoietic stem cell transplant.
4. 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 least 28 days (four weeks) prior to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg) or equivalent other steroid dose is allowable.
5. 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.
6. 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).
7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects \> 16 years old) score ≥ 50.
8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea or low-dose cytarabine (up to 100 mg/m2/dose)
9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age.
10. AST/ALT ≤ 5 x ULN for age
11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%.
12. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Exclusion Criteria
2. Patients with down syndrome.
3. Patients with Acute Promyelocytic leukemia (APL) or Juvenile Myelomonocytic Leukemia (JMML).
4. Patients with Bone Marrow Failure Syndrome.
5. Pregnant subjects or those unwilling to use an effective method of birth control.
6. Female subjects with infants who do NOT agree to abstain from breastfeeding.
7. Inability or unwillingness of legal guardian/representative to give written informed consent.
8. Patients with uncontrolled systemic fungal, bacterial, viral or other infection.
21 Years
ALL
No
Sponsors
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Gateway for Cancer Research
OTHER
Norman J. Lacayo
OTHER
Responsible Party
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Norman J. Lacayo
Instructor Pediatrics - Hematology/Oncology
Principal Investigators
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Norman Lacayo, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Universiy
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Stanford University
Stanford, California, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Pennsylvania State University Hershey Medical Center
Hershey, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PEDSHEMAML0008
Identifier Type: OTHER
Identifier Source: secondary_id
POE22-01
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00060706
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-66573
Identifier Type: -
Identifier Source: org_study_id
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