TerminatedPhase 1/2

A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Stopped: Phase 1 enrollment was terminated due to dose-limiting toxicities, thus the study was terminated by Sponsor.

United States11 participantsStarted 2021-02-24

Plain-language summary

This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment. The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects, and to evaluate if participant's leukemia achieves remission. Participants will take ponatinib tablets with chemotherapy. For participants who cannot swallow tablets or who are receiving less than a 10 milligrams (mg) dose, a capsule with small ponatinib minitablets inside will be provided. Participants will take ponatinib for 10 weeks in combination with chemotherapy (reinduction and consolidation blocks) and will be followed up for at least 3 years.

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria

✓. Participants must have a diagnosis of Ph+ ALL, Philadelphia chromosome-positive plus mixed phenotype acute leukemia (Ph+ MPAL), or Ph-like ALL with:
✓. Weight: Participants must be weighing at least 5 kg at the time of enrollment.
✓. Performance Status: Karnofsky performance status ≥50% for participants ≥16 years of age or Lansky Play Scale ≥50% for participants \<16 years of age.
✓. Have recovered to less than Grade 2 National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0, or to baseline, from any nonhematologic toxicities (except alopecia) due to previous therapy.
✓. Participants must meet the following criteria related to prior therapies:
✓. a) Adequate renal function defined as: Estimated glomerular filtration rate (eGFR) using the Schwartz formula, OR radioisotope glomerular filtration rate (GFR)≥70 mL/min/1.73 m\^2, OR a normal serum creatinine based on age and sex.
✓. No clinical, radiological or laboratory evidence of pancreatitis, including:
✓. Serum lipase must be \<2 times the ULN, AND

Exclusion criteria

What they're measuring

Phase 1: Recommended Phase 2 Dose (RP2D) of Ponatinib in Combination With Chemotherapy

Timeframe: Up to Day 35 in Phase 1

Phase 2: Percentage of Participants With Complete Remission (CR) at the End of the Reinduction Block

Timeframe: Up to Day 35 in Phase 2

Trial details

NCT IDNCT04501614

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-19

Results submitted2024-12-19

View on ClinicalTrials.gov More Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL) trials