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Status:

ACTIVE_NOT_RECRUITING

Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL

Lead Sponsor:

Gruppo Italiano Malattie EMatologiche dell'Adulto

Conditions:

Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

ALL, Adult

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This is a randomised, open-label, multicenter, phase III study for adult de novo Ph+ ALL patients based on the combination of Ponatinib with Blinatumomab. The control arm will be represented by a chem...

Detailed Description

This is a randomised, open-label, multicenter, phase III study for adult de novo Ph+ ALL patients (≥18 years, no upper age-limit) based on the combination of the pan-TKI Ponatinib, with the bispecific...

Eligibility Criteria

Inclusion

  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • Newly diagnosed adult B-precursor Ph+ ALL patients.
  • WHO performance status less or equal to 2.
  • Age greater or equal to18 years, with no upper age limit.
  • Renal and hepatic function as defined below:
  • AST (GOT), ALT (GPT), and AP \<2 x upper limit of normal (ULN).
  • Total bilirubin \<1.5 x ULN.
  • Creatinine clearance equal or greater than 50 mL/min.
  • Pancreatic function as defined below:
  • Serum amylase less or equal to 1.5 x ULN and serum lipase less or equal to1.5 x ULN.
  • Normal cardiac function.
  • No evidence of CNS leukemia at blinatumomab start.
  • Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test.
  • Negative pregnancy test in women of childbearing potential.
  • Bone marrow specimen from primary diagnosis available.

Exclusion

  • History of or current relevant CNS pathology (ongoing grade ≥2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson's disease, organic brain syndrome, psychosis).
  • Impaired cardiac function, including any one of the following:
  • LVEF \<45% as determined by MUGA scan or echocardiogram.
  • Complete left bundle branch block.
  • Use of a cardiac pacemaker.
  • ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.
  • Congenital long QT syndrome.
  • History of or presence of significant ventricular or atrial arrhythmia.
  • Clinically significant resting bradycardia (\<50 beats per minute).
  • QTc \>450 msec on screening ECG (using the QTcF formula).
  • Right bundle branch block plus left anterior hemiblock, bifascicular block.
  • Myocardial infarction within 3 months prior to starting Ponatinib.
  • Angina pectoris.
  • Other clinically significant vascular and heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Ponatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL).
  • Taking medications that are known to be associated with Torsades de Pointes and medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
  • History of or current autoimmune disease.
  • Systemic cancer chemotherapy within 2 weeks prior to study.
  • Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
  • Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.
  • Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
  • Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.

Key Trial Info

Start Date :

September 8 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2027

Estimated Enrollment :

236 Patients enrolled

Trial Details

Trial ID

NCT04722848

Start Date

September 8 2021

End Date

September 1 2027

Last Update

January 23 2025

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia

Ascoli Piceno, Italy

2

Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia

Bari, Italy

3

Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia

Bergamo, Italy

4

As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo

Bolzano, Italy