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Ponatinib Plus Reduced-intensity Chemotherapy in the First-line Treatment of Adult Patients With Ph+ ALL

NCT04554459 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-08-14

No results posted yet for this study

Summary

This is a phase II interventional trial to evaluate the efficacy of ponatinib plus reduced-intensity chemotherapy in the first-line treatment of adult patients with Ph+ acute lymphoblastic leukemia. This combination has the potential to improve the depth of molecular responses after the induction phase of treatment. Patients who achieve a complete molecular response (CMR) at week 11 will not be directed to alloSCT and will receive consolidation chemotherapy combined with ponatinib, followed by 24 months of ponatinib maintenance. The aim is to spare individuals with a low probability of relapse from overtreatment with more intensive and toxic transplant procedure.

Conditions

  • Acute Lymphoblastic Leukemia, Adult
  • Ph+ ALL
  • Newly Diagnosed

Interventions

DRUG

Ponatinib 15 MG Oral Tablet

ponatinib plus reduced-intensity chemotherapy in first-line treatment of Adult Ph+ ALL

Sponsors & Collaborators

  • CZECRIN - Czech Clinical Research Infrastructure Network

    collaborator UNKNOWN

  • Institute of Hematology and Blood Transfusion, Czech Republic

    lead OTHER

Principal Investigators

  • Cyril Salek, MD · Institute of Hematology and Blood Transfusion, Czech Republic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2023-09-01
Completion
2024-07-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554459 on ClinicalTrials.gov