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    Summary
    EudraCT Number:2021-003596-34
    Sponsor's Protocol Code Number:CHDM201K12201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-03-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003596-34
    A.3Full title of the trial
    A phase Ib/II, open label study of siremadlin monotherapy and in combination with donor lymphocyte infusion as a treatment for patients with acute myeloid leukemia post-allogeneic stem cell transplantation who
    are in complete remission but at high risk for relapse.
    Studio di Fase Ib/II, in aperto, con siremadlin in monoterapia e in associazione a infusione di linfociti del donatore per il trattamento dei pazienti con leucemia mieloide acuta post-trapianto allogenico di cellule staminali che sono in remissione completa ma a rischio elevato di recidiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of efficacy and safety of siremadlin alone and in combination with donor lymphocyte infusion (DLI) in adults with acute myeloid leukemia (AML) who have received allogeneic stem cell transplant (allo-SCT) but are at high risk for relapse.
    -
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberCHDM201K12201
    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 SponsorNOVARTIS PHARMA AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA S.p.A.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio (VA)
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390296541
    B.5.5Fax number0039029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namesiremadlin
    D.3.2Product code [HDM201]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSIREMADLIN
    D.3.9.2Current sponsor codeHDM201
    D.3.9.4EV Substance CodeSUB198077
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namesiremadlin
    D.3.2Product code [HDM201]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSIREMADLIN
    D.3.9.2Current sponsor codeHDM201
    D.3.9.4EV Substance CodeSUB198077
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Myeloid Leukemia
    -
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid 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 10000886
    E.1.2Term Acute myeloid 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
    Safety Primary Objectives:
    • To determine the dose and schedule of siremadlin monotherapy that is tolerable without unacceptable toxicities (recommended dose for priming), measured by incidence of dose-limiting toxicities (DLTs).
    • To determine the dose and schedule of siremadlin in combination with DLI that is tolerable without unacceptable toxicities (maximum recommended dose for combination), measured by time to DLT.
    Efficacy Primary Objectives:
    • To evaluate the preliminary efficacy of siremadlin (priming monotherapy, in combination with DLI after priming monotherapy and as monotherapy maintenance subsequent to priming or combination with DLI) on prevention of hematologic relapse, measured by the proportion of participants who are alive and maintained CR or CRi with no evidence of hematologic relapse over at least 6 months after start of study treatment.
    -
    E.2.2Secondary objectives of the trial
    • To assess relapse free survival (RFS).
    • To assess cumulative incidence of relapse at 1 year and at 2 years after start of study treatment.
    • To assess overall survival (OS).
    • To assess the effect of study treatment on MRD status within the first 6 months of study treatment.
    • To assess safety and tolerability of siremadlin monotherapy (during priming and maintenance) and in combination with DLI.
    • To assess the proportion of participants stopping study treatment due to GvHD or other adverse events
    • To assess the incidence of grade III and IV acute graft vs host disease (GvHD), moderate and severe chronic GvHD.
    • To assess GvHD-free/relapse-free survival (GRFS).
    • To characterize the pharmacokinetics of siremadlin in monotherapy and in combination with DLI.
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study.
    2. Adults >= 18 years of age.
    3. Participants with AML diagnosis, who underwent one allo-SCT to treat AML and are currently at Day >=60 but no later than Day 120 (= Day 120) post allo-SCT. patients who received high-dose cyclophosphamide early post non-haploidentical transplant for prevention of GvHD are eligible if they are between Day >=60 and <= Day 150 post-allo-SCT at study entry.
    4. Pre-allo-SCT - Participants must have any of the following risk factors that put them at high risk for relapse:
    • AML in first CR (CR1) prior to allo-SCT with one of the following:
    • Adverse risk genetic abnormalities per 2017 ELN risk stratification.
    patients with TP53 mutant AML at diagnosis are eligible if they meet eligibility criteria.
    • Therapy-related AML (t-AML).
    • Secondary AML (sAML) [AML secondary to antecedent myelodysplastic syndrome (MDS) or AML secondary to myeloproliferative neoplasm (MPN)].
    • AML in second or greater CR (>=CR2) prior to allo-SCT.
    • AML in complete morphologic
    • remission (<5% leukemic blasts) at time of transplant (within 30 days of transplant / prior to starting conditioning regimen) but with evidence of residual leukemia.
    5. Allo-SCT must have the following characteristics:
    • Unmanipulated/T cell-replete bone marrow or peripheral blood stem cells as a graft source.
    • Matched related (family) donor (MFD) or matched unrelated donor (MUD): Human Leukocyte Antigen (HLA) matching of donor and recipient should be at a minimum of 8/8 antigen or allele matched at HLA-A, -B, -
    C, -DRB1 loci.
    • Any conditioning regimen intensity is permitted, the use of antithymocyte globulin (ATG) or alemtuzumab or post-transplant cyclophosphamide as a part of conditioning is allowed.
    6. Donor lymphocytes are collected, cryopreserved and available for infusion (DLI), or obtaining donor lymphocytes for DLI is feasible.
    7. Post-allo-SCT, participants must have achieved complete remission (CR) or CR with incomplete count recovery (CRi) with no current evidence of hematologic relapse (bone marrow blasts <5%; no circulating blasts in the blood; no evidence of extramedullary disease).
    8. Systemic GvHD prophylaxis or treatment [immunosuppressive treatment (IST)] taper has been started prior to start of study treatment or has been completed.
    9. Ability to provide a fresh bone marrow aspirate sample collected within 28 days from enrollment, and immediately shipped to a Novartis designated central laboratory for MRD testing.
    10. Adequate liver function tests (AST and ALT <= 3 × ULN, total bilirubin <= 1.5 × ULN) and renal function (estimated Glomerular Filtration Rate (eGFR) = 45 mL/min/1.73 m2) (within 14 days prior to start of study treatment).
    11. Evidence of adequate engraftment post allo-SCT: ANC >= 1.0x109/L, platelet count >= 75x109/L, hemoglobin >= 8 g/dL (within 14 days prior to start of study treatment).
    -
    E.4Principal exclusion criteria
    1. Prior exposure to MDM-inhibitor.
    2. Active acute GvHD of any grade (per Harris et al 2016) requiring systemic therapy at time of study treatment initiation.
    3. Active chronic GvHD of any grade (per NIH criteria (Jagasia et al 2015) requiring systemic therapy at time of study treatment initiation.
    4. Past history of grade III or IV acute GvHD (per Harris et al 2016) and/or past history of moderate or severe chronic GvHD (per NIH criteria (Jagasia et al 2015)).
    5. Recipient of allo-SCT from a matched unrelated donor (MUD) with one or more antigen or allele mismatch at HLA-A, -B, -C, -DRB1 locus (HLA matching less than 8/8 antigens).
    6. Recipient of allo-SCT from a haploidentical family donor.
    7. Recipients of cord blood transplant as a graft source.
    8. Prior systemic cancer-directed treatments or investigational modalities <= 5 half-lives or 4 weeks prior to starting study, whichever is shorter.
    9. Prior systemic AML-directed treatments given at any time after allo-SCT (including DLI).
    10. History of another primary malignancy that is currently clinically significant or currently requires active intervention. Participants who are receiving adjuvant therapy such as hormone therapy are eligible.
    11. Participants who require treatment with moderate or strong CYP3A inducers within 14 days prior to starting study treatment, or are expected to receive moderate or strong CYP3A4 inducers during the entire study.
    12. GI disorders that may prevent the intake and absorption of oral siremadlin (eg, diarrhea, uncontrolled nausea and/or vomiting, GI bleeding, etc).
    13. Any concurrent severe and/or active uncontrolled bacterial, viral or fungal infection requiring parenteral antibacterial, antiviral or antifungal therapy. Prophylactic antimicrobial use (oral or parenteral) is allowed.
    14. Cardiac or cardiac repolarization abnormality, including but not limited to any of the following:
    • History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.
    • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block).
    • Baseline QTcF interval > 470 ms.
    • Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade III/IV).
    15. Other concurrent severe and/or uncontrolled medical conditions or serious organ dysfunction or other co-morbidity that, in the opinion of the investigator, predisposes the participant o high risk of noncompliance with the protocol.
    -
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Incidence of DLTs with siremadlin monotherapy in priming phase
    • Time to DLT with siremadlin/DLI in combination phase
    Efficacy:
    • Proportion of participants who are alive and maintained CR or CRi with no evidence of hematologic relapse over at least 6 months after start of study treatment (siremadlin monotherapy, as priming and/or maintenance, with or without siremadlin in combination with DLI).
    -
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Primary safety endpoint in priming phase will take place after each dose escalation cohort with required number of participants in dosedetermining set 1 (DDS1) completes the one-cycle (4 weeks) DLT observation period.
    2. Primary safety endpoint in combination phase: Safety assessments will be conducted after each cohort of 3 participants completed the first siremadlin/DLI treatment cycle or experienced a DLT. The final safety
    assessment will take place after all participants in dose-determining set 2 (DDS2) complete combination phase.
    3. Primary efficacy endpoint: The primary efficacy analysis will be performed on all participant data at the time all participants who are still receiving study treatment will have completed at least 6 months or discontinued earlier.
    -
    E.5.2Secondary end point(s)
    • Time from start of study treatment to the date of first documented hematologic relapse or death due to any cause, whichever occurs first
    • Cumulative incidence of AML relapse at 1 year and at 2 years after start of study treatment
    • Time from start of study treatment to the date of death from any cause.
    • MRD status of participants at baseline and within the first 6 months of study treatment
    • Incidence and severity of AEs and SAEs, changes in laboratory values and vital signs.
    • Proportion of participants with permanent discontinuation of study treatment due to GvHD or other adverse events.
    • Incidence of treatment emergent grade III or grade IV aGvHD. Incidence of treatment emergent moderate to severe cGvHD.
    • Time from start of study treatment to the date of first documented occurrence or worsening of treatment emergent grade III or IV aGvHD, cGvHD requiring initiation of systemic immunosuppressive treatment, occurence of disease relapse, or death due to any cause, whichever occurs first.
    • Pharmacokinetic parameters (e.g., AUC, Cmax, Tmax) and concentration vs time profiles of siremadlin in monotherapy and in combination with DLI.
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated at the primary efficacy analysis and final analysis (at the end of study):
    Time point for PK in monotherapy is both primary efficacy analysis and final analysis (end of study), while time point for PK in combination with DLI is final analysis.
    -
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    -
    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
    Phase Ib/II proof of concept study
    -
    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 Yes
    E.8.1.7.1Other trial design description
    -
    Open label
    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.8.2.4Number 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Israel
    United States
    Germany
    Italy
    United Kingdom
    Spain
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    -
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 32
    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)
    At the end of the study, in alignment with local regulations, treatment continuity will be offered outside this study through an alternative setting to participants who are receiving treatment with siremadlin and in the opinion of investigator are still deriving clinical benefit. Safety will be monitored and reported to Health Authorities as per regulatory requirements.
    -
    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 Decision2022-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-10-18
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