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    Summary
    EudraCT Number:2013-000706-36
    Sponsor's Protocol Code Number:20120216
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-14
    Trial results View 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 ConcernedGermany - PEI
    A.2EudraCT number2013-000706-36
    A.3Full title of the trial
    A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Phase 2 Study to evaluate the efficacy of the bispecific antibody blinatumomab in adult subjects with Philadelphia Positive Acute Lymphoblastic Leukemia (PH+ ALL) that did not respond to previous therapy or that relapsed after initially successful previous therapy.
    A.3.2Name or abbreviated title of the trial where available
    Alcantara Study
    A.4.1Sponsor's protocol code number20120216
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02000427
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 No
    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/3/09/650
    D.3 Description of the IMP
    D.3.1Product nameBlinatumomab
    D.3.2Product code AMG 103, MT103
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBlinatumomab
    D.3.9.1CAS number 853426-35-4
    D.3.9.2Current sponsor codeAMG 103
    D.3.9.3Other descriptive nameBLINATUMOMAB
    D.3.9.4EV Substance CodeSUB35403
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Adult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALL
    E.1.1.1Medical condition in easily understood language
    Acute lymphoblastic leukemia - a cancer of the blood and marrow
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000012958
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10063625
    E.1.2Term Acute lymphoblastic leukemia recurrent
    E.1.2System Organ Class 100000012975
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the rate of complete remission/complete remission with partial hematological recovery (CR/CRh*) in adult subjects with Relapsed/Refractory (R/R) Philadelphia Chromosome Positive (Ph+) B-precursor Acute Lymphoblastic Leukemia (ALL) who receive blinatumomab
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • To evaluate the rate of Minimal Residual Disease (MRD) remission in adult subjects with R/R Ph+ B-precursor ALL
    • To evaluate other measures of efficacy of blinatumomab in adult subjects with R/R Ph+ B-precursor ALL
    • To estimate the safety of blinatumomab in adult subjects with R/R Ph+ B-precursor ALL
    • To evaluate pharmacokinetics (PK) of blinatumomab in adult subjects with R/R Ph+ B-precursor ALL
    Exploratory Objectives:
    • To evaluate the duration of MRD response
    • To evaluate the efficacy of blinatumomab against specific bcr-abl mutations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with Ph+ B-precursor ALL, with any of the following:
    • Relapsed or refractory to at least one second generation TKI (dasatinib, nilotinib, bosutinib, ponatinib)
    OR intolerant to second generation TKI and intolerant or refractory to imatinib mesylate
    2. Greater than 5% blasts in bone marrow
    3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    4. Age ≥ 18 years of age, at the time of informed consent
    5. Subject has provided informed consent or subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
    E.4Principal exclusion criteria
    1. History of malignancy other than ALL within 5 years prior to start of protocol-required therapy with the exception of:
    − Malignancy treated with curative intent and with no known active disease present for 5 years before enrollment and felt to be at low risk for recurrence by the treating physician
    − Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    − Adequately treated cervical carcinoma in situ without evidence of disease
    − Adequately treated breast ductal carcinoma in situ without evidence of disease
    − Prostatic intraepithelial neoplasia without evidence of prostate cancer
    2. History or presence of clinically relevant CNS pathology as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis
    − With the exception of CNS leukemia that is well controlled with intrathecal therapy
    3. Active ALL in the CNS (confirmed by CSF analysis) or testes (no clinical sign thereof)
    4. Isolated extramedullary disease
    5. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
    6. Allogeneic HSCT within 12 weeks prior to start of blinatumomab
    7. Any active acute Graft-versus-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
    8. Any systemic therapy against GvHD within 2 weeks prior to start of blinatumomab
    9. Cancer chemotherapy within 2 weeks prior to start of blinatumomab (intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab). In addition, any subject whose organ toxicity (excluding hematologic) from prior ALL treatment has not resolved to no more than CTCAE grade 1.
    10. Immunotherapy (eg, rituximab) within 4 weeks prior to start of blinatumomab
    11. Subject received prior anti-CD19 therapy
    12. Eligibility for alloHSCT at the time of enrollment (as defined by disease status, performance status and availability of donor)
    13. Abnormal screening laboratory values as defined below:
    − AST (SGOT) and/or ALT (SGPT) and/or alkaline phosphatase ≥ 5 x upper limit of normal (ULN)
    − Total bilirubin ≥ 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
    − Creatinine ≥ 1.5 ULN or creatinine clearance < 60 mL/min (calculated)
    14. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
    15. Subject is pregnant or breast feeding, or might become pregnant within 3 months after the last dose of protocol-specified therapy
    16. Woman of childbearing potential and is not willing to use 2 highly effective methods of contraception while receiving blinatumomab and for an additional 3 months after the last dose of protocol-specified therapy
    17. Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception for at least an additional 3 months after the last dose of protocol-specified therapy
    18. Male who has a pregnant partner, and is not willing to use a condom during sexual activity for 3 months after the last dose of protocol-specified therapy
    19. Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study(s). The 30 days is calculated from day 1 of blinatumomab treatment.
    20. Other investigational procedures while participating in the treatment portion of this study are excluded.
    21. Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
    22. Subject previously entered into this study or previous treatment with blinatumomab.
    23. Subject likely to not be available to complete all protocol-required study isits or procedures, including follow-up visits, and/or to comply with all required study procedures including writing tests to the best of the subject and Investigator’s knowledge.
    24. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    E.5 End points
    E.5.1Primary end point(s)
    CR/CRh* rate within 2 cycles of treatment with blinatumomab
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment at the end of the first and second treatment cycle
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    1. Rate of MRD remission within 2 cycles of treatment with blinatumomab
    2. Duration of CR or CRh*
    3. CR rate within 2 cycles of treatment with blinatumomab
    4. CRh* rate within 2 cycles of treatment with blinatumomab
    5. CR+CRh*+ Complete Response incomplete (CRi) rate within 2 cycles of treatment with blinatumomab
    6. Overall survival
    7. Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) and 100-day mortality after alloHSCT
    8. Incidence of adverse events and antibody formation
    9. Pharmacokinetic parameters: Serum concentration of blinatumomab
    Exploratory Endpoints:
    1. Duration of MRD Remission with blinatumomab treatment
    2. Efficacy of blinatumomab against specific bcr-abl mutations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints:
    1+3+4+5: Assessment at the end of the first and second treatment cycle
    2: Assessment at the end of each treatment cycle, 30 days after last dose (safety follow-up) and up to 18 months long-term follow-up (every 3 months)
    6: Assessment throughout entire study including treatment, 30 days safety follow-up and up to 18 months long-term follow-up
    7: Assessment throughout entire study and 100 days after alloHSCT
    8: Assessment throughout treatment period and 30 days after last dose (safety follow-up)
    9: Assessment at day 8 of cycle1 and day 1 of cycle 2
    Exploratory Endpoints:
    1+2: Assessment at the end of each treatment cycle, 30 days after last dose (safety follow-up) and up to 18 months long-term follow-up (every 3 months)
    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 Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    France
    Germany
    Italy
    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
    end of study (primary completion): when the last subject is assessed or
    receives an intervention for the purposes of final collection of data for
    the primary endpoint

    end of study (end of trial): when the last subject is assessed or
    receives an intervention for evaluation in the study; including survival
    assessments
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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
    If the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent, the subject’s legally acceptable representative can provide written informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 41
    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)
    None
    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 Decision2013-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-06
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