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    Summary
    EudraCT Number:2022-002989-33
    Sponsor's Protocol Code Number:COLPRIT-0000-BAS-0041-I
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-002989-33
    A.3Full title of the trial
    CHEMOKINE RECEPTOR CXCR4-DIRECTED THERANOSTICS OF ADVANCED LYMPHOPROLIFERATIVE CANCERS BY RADIOPEPTIDE-BASED IMAGING AND THERAPY:
    THE COLPRIT PHASE I/II STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CHEMOKINE RECEPTOR CXCR4-DIRECTED THERANOSTICS OF ADVANCED LYMPHOPROLIFERATIVE CANCERS BY RADIOPEPTIDE-BASED IMAGING AND THERAPY:
    THE COLPRIT PHASE I/II STUDY
    A.3.2Name or abbreviated title of the trial where available
    COLPRIT
    A.4.1Sponsor's protocol code numberCOLPRIT-0000-BAS-0041-I
    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 SponsorKlinikum rechts der Isar der Technischen Universität München
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKlinikum rechts der Isar der Technischen Universität München
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTUM School of Medicine and Health, Münchner Studienzentrum
    B.5.2Functional name of contact pointHelen Bidner
    B.5.3 Address:
    B.5.3.1Street AddressIsmaninger Str. 22
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941406312
    B.5.5Fax number00498941406322
    B.5.6E-mailhelen.bidner@mri.tum.de
    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 name90Y-Pentixather
    D.3.4Pharmaceutical form Solution for injection in vial
    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 INNPentixaTher acetate
    D.3.9.3Other descriptive namePentixather
    D.3.9.4EV Substance CodeSUB271622
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 10098-91-6
    D.3.9.3Other descriptive nameYttrium-90
    D.3.9.4EV Substance CodeSUB90157
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3
    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 Yes
    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
    Indication: Non-Hodgkin lymphomas (NHL)
    Advanced lymphoproliferative cancers: aggressive B- and T- cell Non-Hodgkin lymphomas (NHL), including heavily pretreated transformed indolent lymphoma (tNHL) and multiple myeloma (MM) as a subgroup of B-cell NHL
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin lymphomas (NHL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: The definition of the max. tolerated activity by escalation of 90Y-Pentixather in combination with high dose chemotherapy according to SOC (e.g. Melphalan, Treosulfan) followed by autoSCT.
    Phase II: to evaluate the overall response rate (ORR) of the treatment regime established in the phase I part of the clinical trial
    E.2.2Secondary objectives of the trial
    Phase I: Assessment of the radiation dose received by the patient.
    Phase II: Median PFS, OS, safety and tolerability, hematopoietic recovery (measured with CBCs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven diagnosis of one of the following active measurable lymphoproliferative malignancies (as defined in chapter 10.1):
    a) Multiple myeloma (progression after conventional chemotherapy, at least one proteasome inhibitor and one immunomodulatory drug, and high-dose chemotherapy with autoSCT, not currently suitable for allogeneic hematopoietic stem cell transplantation [alloSCT])
    b) Aggressive B- and T-NHL including heavily pretreated transformed indolent lymphoma (tNHL) (refractory or relapsed disease after extensive pretreatment with min. 2 regimes, at least one including an anti-CD20 antibody, or after standard high-dose chemotherapy with autoSCT), not currently suitable for alloSCT
    2. Inclusion of patients with preceded CAR-T cell therapy is allowed but not a perquisite if such a therapy is not indicated or available at the time point of inclusion
    3. Positive 68Ga -Pentixafor PET/CT imaging. In patients with MM 68Ga-Pentixafor-PET/CT may be replaced by 68Ga-Pentixafor-PET/MR
    4. Bone marrow aspirate and biopsy (according to clinical routine from last lymphom/myelom specific therapy or 3 - 4 months prior to Baseline) for assessment of pathology, cytology and immunohistochemistry and/or flow cytometry for CXCR4 (CD184) expression
    5. Availability of CD34+ peripheral blood hematopoietic stem cells (CD34+ HSC), > 2x106 CD34+HSC / kg body weight) prior to enrolment, obtained during a previous treatment line, including HSC intended for backup use
    6. Age ≥ 18 years
    7. Eastern cooperative oncology group (ECOG) performance status 0-1 and life expectancy > 3 months and deemed fit for high-dose chemotherapy and autologous stem-cell transplantation
    8. Adequate hematopoetic, hepatic (ALAT/ASAT <5x ULN, total Bilirubin <2.5x ULN), renal (CreaCl>40ml/min), cardiac and pulmonary function, excluding organ dysfunctions associated with the underlying disease.
    9. Women of childbearing potential (WOCBP) must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are for example implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence (defined as refraining from heterosexual intercourse during the clinical trial) or vasectomized partner. Those contraceptive measures should be applied for 30 days after visit 3
    Men with child bearing potential (CBP) must either use a condom, must be vasectomized or stay sexual abstinent (defined as refraining from heterosexual intercourse during the clinical trial). Contraception for WOCBP – as above mentioned – should be considered. Those contraceptive measures should be applied for 90 days after visit 3.
    10. Written informed consent
    E.4Principal exclusion criteria
    1. Evidence of active concurrent malignant disease
    2. Evidence of rapid progress of underlying diseases with severely limited life expectancy (< 3 months)
    3. Evidence of significant, uncontrolled acute or chronic concomitant diseases that could affect compliance with the protocol or interpretation of results including contraindications against CT-/MRI-/PET-Scans or against myeloablative therapy followed by autoSCT
    4. Study participants with discrepant lesions in FDG PET cannot be included
    5. Uncontrolled active or chronic infection, including hepatitis B and/or C (Anti-HbS, HbS-AG) and HIV (Anti-HIV)
    6. Patients with a history of psychiatric illness or condition that could interfere with their ability to understand the requirements of the clinical trial
    7. Previous or concurrent participation in another clinical study involving trial medication within the preceding 12 weeks (prior to Baseline) or previous participation in this clinical trial
    8. Pregnancy or breast-feeding women
    9. Known hypersensitivity to the IMP or NIMP/AxMP or any agent given in association with this clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: Determination of maximum tolerated dose (MTD)
    Phase II: ORR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: from Baseline to Visit 4
    Phase II: 9 weeks
    E.5.2Secondary end point(s)
    Phase I: The dosimetric analysis for the assessment of the radiation dose received by the patient.
    Phase II: Median PFS, OS, hematopoietic recovery (measured with the time course of CBCs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase II: 24 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 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 Yes
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state38
    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 Decision2023-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-29
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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