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    Summary
    EudraCT Number:2019-002549-39
    Sponsor's Protocol Code Number:Ponatinib-1501
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-10-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-002549-39
    A.3Full title of the trial
    A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ponatinib With Chemotherapy in Pediatric Patients With Relapsed, Resistant, or Intolerant Ph+ ALL or Have the T315I Mutation
    A.4.1Sponsor's protocol code numberPonatinib-1501
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04501614
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1225-0394
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/293/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center Americas, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointDeborah Bruce
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avenue
    B.5.3.2Town/ cityLexington, MA
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+447507041766
    B.5.6E-maildeborah.bruce@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ICLUSIG
    D.2.1.1.2Name of the Marketing Authorisation holderIncyte Biosciences Distribution B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/715
    D.3 Description of the IMP
    D.3.1Product namePonatinib
    D.3.2Product code Ponatinib
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPonatinib
    D.3.9.1CAS number 1114544-31-8
    D.3.9.2Current sponsor codePON
    D.3.9.3Other descriptive namePONATINIB HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB121686
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute lymphoblastic leukemia
    E.1.1.1Medical condition in easily understood language
    leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1
    - To determine the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy.

    Phase 2
    - To determine the efficacy of ponatinib in combination with chemotherapy as measured by the rate of CR at the
    end of the reinduction block.
    E.2.2Secondary objectives of the trial
    Phase 1
    - To define and describe the phase 1 efficacy of ponatinib (tablet and AAF) in combination with chemotherapy.
    - To characterize BCR-ABL1 domain mutations both prior to and following ponatinib treatment.

    Phase 2
    - To describe the proportion of patients in continued CR or who achieve CR at the end of consolidation and the proportion of patients with minimal residual disease (MRD) status <0.01% at the end of each treatment block.
    - To determine the proportion of patients who relapsed or progressed.
    - To determine event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) at 6 months, 1 year, 18 months, 2 years, and 3 years.
    - To determine duration of response (for CR).
    - To determine the proportion of patients who underwent hematopoietic stem cell transplantation (HSCT)
    following study treatment.
    - To characterize BCR-ABL1 domain mutations both prior to and following ponatinib treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis: Patients must have a diagnosis of ALL or MPAL with definite evidence of BCR-ABL1 fusion (Ph) or Ph-like ALL (US only) with targetable kinase-activating lesions and either (i) or (ii) as follows:
    (i) For non-US sites: patients who have relapsed or are resistant or intolerant to at least 1 prior therapy that contained a BCR-ABL1–targeted TKI; OR
    For US sites: patients who have relapsed or are resistant or intolerant to at least 1 prior therapy that
    contained a second-generation BCR-ABL1–targeted TKI (ie, dasatinib, nilotinib, and bosutinib); OR
    (ii) Have a BCR-ABL1 T315I mutation. Referring institutions laboratory results will be accepted for
    enrollment.

    a. Patients in relapse (post 0 or 1 HSCT).
    b. Patients with BCR-ABL1 T315I mutation, irrespective of relapse, resistance/intolerance, or transplant status, and irrespective of any prior TKI use.
    c. Patients with Ph-like ALL (US only) with TKI-targetable lesions involving any of the following kinase
    genes: ABL1, ABL2, CSF1R, and PDGFRB.
    d. Patients with bone marrow relapse defined as: M2 marrow (5%-24% lymphoblasts) by morphology with confirmatory testing consisting of ≥5% lymphoblasts by flow cytometry or BCR-ABL1 fluorescence in situ hybridization (FISH) or ≥10-2 leukemic clone identified by immunoglobulin heavy chain–T-cell receptor polymerase chain reaction (PCR) or M3 marrow (≥25% lymphoblasts) by morphology.
    e. Patients with combined bone marrow and extramedullary disease.
    2. Age: Patients must be ≥1 and ≤21 years of age at the time of enrollment.
    3. Performance Status: Karnofsky performance status ≥50% for patients >16 years of age or Lansky Play Scale ≥50% for patients ≤16 years of age.
    4. Patients must have recovered to less than Grade 2 National Cancer Institute Common Terminology Criteria for Adverse Events version 5, or to baseline, from any nonhematologic toxicities (except alopecia) due to previous therapy.
    5. Patients must meet the following criteria related to prior therapies:
    Cytoreduction with hydroxyurea: Hydroxyurea can be initiated and continued for up to 24 hours before the start of protocol therapy.
    Patients who relapsed while receiving cytotoxic therapy: At least 14 days must have passed since the
    completion of the last dose of chemotherapy before the first dose of ponatinib can be given except for the following: intrathecal chemotherapy and/or maintenance therapy such as vincristine, mercaptopurine, methotrexate, or glucocorticoids. There is no waiting period for those relapsing on maintenance-like therapy.
    HSCT: Patients who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days posttransplant at the time of enrollment.
    Hematopoietic growth factors: Before the first dose of ponatinib, at least 7 days must have passed since completion of therapy with granulocyte colony-stimulating factor or other growth factors, and at least 14 days must have passed since completion of therapy with pegfilgrastim.
    Biologics and targeted therapies: Before the first dose of ponatinib, at least 7 days must have passed since the last dose of a biologic agent. For agents that have known AEs occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor’s medical monitor/designee.
    Monoclonal antibodies: After the last dose of monoclonal antibody, at least 3 half-lives of the administered antibody must have passed before the first dose of ponatinib.
    Immunotherapy: Before the first dose of ponatinib, at least 30 days must have passed after the completion of any type of immunotherapy (eg, tumor vaccines, chimeric antigen receptor T-cell [CAR-T cell]).
    Immunosuppressive therapy: Before the first dose of ponatinib, at least 14 days must have passed after the completion of immunosuppressive therapy (including regimens following stem cell transplant).
    Radiotherapy: No washout period is necessary for radiation given to any extramedullary site other than central nervous system (CNS); ≥90 days must have passed if patient received prior total body irradiation or craniospinal or cranial radiotherapy.
    Anthracyclines: Patients must have had a lifetime exposure of <400 mg/m2 of doxorubicin equivalents of anthracyclines.
    6. Patients must have adequate renal and hepatic function.
    7. No clinical, radiological or laboratory evidence of pancreatitis, including:
    a. Serum lipase must be <2 times the ULN, and
    b. Serum amylase must be <2 times the ULN.
    8. Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram (ECHO) OR left ventricular ejection fraction of ≥50% by multigated acquisition scan (MUGA).
    9. Normal QT interval corrected per Fridericia method (QTcF) on screening electrocardiogram (ECG), defined as QTcF of ≤450 ms.
    E.4Principal exclusion criteria
    1. A history or current diagnosis of Burkitt leukemia/lymphoma or mature B-cell leukemia.
    2. A history or current diagnosis of CML.
    3. Diagnosis of ALL, MPAL, or Ph-like ALL (US only) with targetable kinase-activating lesions after treatment with cytotoxic therapy for another cancer.
    4. Diagnosis of another concurrent primary malignancy.
    5. Clinically significant cardiovascular disease, including but not limited to:
    a. Any history of myocardial infarction (MI) or unstable angina.
    b. History of or presence of heart block, and/or clinically significant ventricular or atrial
    arrhythmias.
    c. Uncontrolled hypertension, defined as persistent elevation of systolic and/or diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management.
    6. Current systemic use of drug(s) that are known to have a risk of causing prolonged corrected
    QT interval (QTc) or torsades de pointes unless drug(s) can be changed to acceptable
    alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system) or the patient can safely discontinue the drug(s).
    7. Uncontrolled hypertriglyceridemia (triglycerides ≥450 mg/dL). (Patients with triglycerides
    ≥450 mg/dL may be enrolled in the absence of any significant cardiovascular risk after discussion with the sponsor’s medical monitor/designee)
    8. Current systemic use of any medications or herbal supplements that are known to be strong inhibitors or strong inducers of CYP3A within 7 days before the first dose of study drug.
    9. Previous treatment with ponatinib.
    10. Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or
    immunotherapy while patient is on study treatment.
    11. Known allergy to any of the drugs (active or excipient) used in the study.
    12. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption of ponatinib.
    13. Patients with DNA fragility syndromes, such as Fanconi anemia and Bloom syndrome.
    14. Patients with Down syndrome.
    15. Ongoing or active systemic infection, known seropositive HIV, or known active hepatitis B or C infection.
    16. Patients with pre-existing significant CNS pathology including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination /movement disorder, or autoimmune disease with CNS involvement are not eligible.
    17. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. (Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved.)
    18. Uncontrolled seizure disorder. (Patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs are eligible.)
    19. History of severe coagulopathy or vascular events.
    20. Any condition or illness that, in the opinion of the investigator or sponsor, would compromise patient safety or interfere with the evaluation of the safety or efficacy of ponatinib.
    21. Admission or evidence of illicit use, drug abuse, or alcohol abuse.
    22. Pregnancy and breastfeeding exclusions:
    a. Female patients who are pregnant are excluded since fetal toxicities and teratogenic effects have been noted
    for several of the study treatments. A pregnancy test is required for female patients of childbearing potential.
    b. Lactating women who plan to breastfeed their infants.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    - RP2D of ponatinib (tablet and AAF) in combination with chemotherapy.

    Phase 2
    - CR at the end of the reinduction block. CR is defined as <5% blasts in bone marrow, normal maturation of all cellular components in the bone marrow, no evidence of extramedullary disease, absolute neutrophil count (ANC) >1000/μL, and platelet count of >100,000/μL
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the reinduction block, both prior to and following ponatinib treatment.
    E.5.2Secondary end point(s)
    Phase 1
    - CR at the end of the reinduction block. CR is defined as <5% blasts in bone marrow, normal maturation of all cellular components in the bone marrow, no evidence of extramedullary disease, ANC >1000/μL, and platelet count of >100,000/μL.
    - Characterization of BCR-ABL1 domain mutations both prior to and following ponatinib treatment.

    Phase 2
    - Proportion of patients in continued CR or who achieve CR at the end of consolidation and the proportion of patients with MRD-negative status (<0.01%) at the end of each treatment block.
    - Proportion of patients who relapsed or progressed.
    - EFS, PFS, and OS at 6 months, 1 year, 18 months, 2 years, and 3 years
    - Duration of response (for CR).
    - Proportion of patients who underwent HSCT following study treatment.
    - Characterization of BCR-ABL1 domain mutations both prior to and following ponatinib treatment.

    Phase 1 PK Endpoint
    - Summary statistics of ponatinib PK parameters including maximum observed plasma concentration (Cmax), time of first occurrence of Cmax (Tmax), and area under the plasma concentration–time curve from time 0 to the time of the last quantifiable concentration (AUClast).

    Phase 1 and Phase 2 Safety Endpoint
    - Adverse events (AEs), serious adverse events (SAEs), arterial occlusive events (AOEs), venous thrombotic/embolic events (VTEs), and any other AEs of special interest (AESIs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the reinduction block, both prior to and following ponatinib treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    safety, tolerability, PK and efficacy of the IP + chemotherapy in pediatric patients
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care / Backbone therapy
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    China
    Czech Republic
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit (follow-up)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 86
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 27
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric Patients starting with 1 year old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 86
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants who have met the primary (and/or secondary) endpoints of the study and, in the opinion of the investigator and confirmed by the sponsor, experienced a clinically meaningful benefit from ponatinib may continue to receive ponatinib in an extension phase of this study or a separate open-label rollover study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-15
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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