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    Summary
    EudraCT Number:2017-002331-41
    Sponsor's Protocol Code Number:HaploMUDStudy
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-10
    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 - PEI
    A.2EudraCT number2017-002331-41
    A.3Full title of the trial
    Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients with Acute Leukemia with Identical GVHD Prophylaxis – A Randomized
    Prospective European Trial
    Passender unverwandter versus haploidenter Spender für allogene Stammzelltransplantation bei Patienten mit Akuter Leukämie – eine randomisierte prospektive europäische Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients with Acute Leukemia with Identical GVHD Prophylaxis
    Passender unverwandter versus haploidenter Spender für allogene Stammzelltransplantation bei Patienten mit Akuter Leukämie – eine randomisierte prospektive europäische Studie
    A.3.2Name or abbreviated title of the trial where available
    HaploMUD
    A.4.1Sponsor's protocol code numberHaploMUDStudy
    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 SponsorUniversity Medical Center Hamburg - Eppendorf
    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 supportDKMS
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Hamburg -- Eppendorf
    B.5.2Functional name of contact pointNicolaus Kroeger
    B.5.3 Address:
    B.5.3.1Street AddressMartinistrasse 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number004904074105 4851
    B.5.5Fax number004904074105 3795
    B.5.6E-mailn.kroeger@uke.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 nameAllogeneic hematopoietic stem cell formulation from peripheral blood.
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    D.3.11.7Plasma derived medicinal product Yes
    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 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
    To compare anti-leukemic activity of allogeneic stem cell trans-plantation for patients with acute leukemia, in complete remis-sion between a 10/10 HLA matched unrelated donor and a haploidentical donor.
    E.2.2Secondary objectives of the trial
    To assess and compare the safety and efficacy of study treat-ments therapy in both study arms on non-relapse mortality (NRM), relapse-free survival (RFS), Overall survival (OS), QOL, toxicity, development of acute and chronic GvDH as well as engraftment and chimerism and impact of measurable residual disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acute Myeloid Leukemia (AML) intermediate or high risk according to ELN or Acute Lymphoblastic Leukemia (ALL) high risk according to ESMO guidelines in 1. CR or AML/ALL in 2. CR, or high risk MDS (according to IPSS-R) in 1. CR or 2. CR.
    2. Patients age: 18 - 70 years at time of inclusion (female and male)
    3. Patients understand and voluntarily sign an informed consent form
    4. ECOG ≤ 2
    5. 10/10 HLA-matched unrelated donor [9/10 mismatch is allowed if HLA mismatch is located in DQB1 (by high resolution typing)] and haploidentical (≥ 5/10 and ≤ 8/10 HLA) relative matched donor available at least 4 weeks after completion of induction and/or consolidation therapy. The mismatch related donor should not be older than 65 years of age.
    6. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol
    E.4Principal exclusion criteria
    1. Severe renal, hepatic, pulmonary or cardiac disease, such as:
    - total bilirubin, SGPT or SGOT > 3 times upper the normal level
    - left ventricular ejection fraction < 30 %
    - creatinine clearance < 30 ml/min
    - DLCO < 35 % and/or receiving supplementary continuous oxygen
    2. Positive serology for HIV
    3. Pregnant or lactating women (positive serum pregnancy test)
    4. Age < 18 and ≥ 71 years.
    5. Uncontrolled invasive fungal infection at time of screening (baseline)
    6. Serious psychiatric or psychological disorders
    7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
    8. Uncontrolled severe autoimmune disease or uncontrolled other malignancy
    9. Availability of an HLA-identical sibling as donor source
    E.5 End points
    E.5.1Primary end point(s)
    1. Relapse incidence at two years between both arms
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Day 30, Day 100, 6 months, 12 months, 24 months
    E.5.2Secondary end point(s)
    1. Overall survival at two years between both arms
    2. Overall survival for all patients assigned to one of the two treatment arms as time to event endpoint
    3. Comparison of GVHD/relapse-free survival as composite endpoint in both arms
    4. Comparison of non-relapsed mortality (NRM) at 1 and 2 years after allogeneic SCT in both arms
    5. Comparison of acute graft-versus-host disease (aGVHD) on day +100 and 1 year (max grade) after allogeneic SCT according to the Glucksberg scale revised by
    Przepiorka et al. between both arms
    6. Comparison of chronic graft-versus-host disease (cGVHD) according to the NIH consensus criteria of Jagasia et al. at 1 and 2 years after allogeneic SCT between both arms
    7. Comparison of toxicity of both regimens scored according to the current version of the NCI CTCAE between both arms
    8. Comparison of immune reconstitution and full donor chimerism between both arms
    9. Evaluation of Sorror Risk Score [8] (Appendix 13.1) on outcome after allogeneic SCT
    10. Comparison of QOL (FACT-BMT) before and after transplantation at + 100 days, 6 months, 1 year, 2 years between both arms
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Day 30, Day 100, 6 months, 12 months, 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    The end of study is at the time when the EU Clinical Trial Directive 2001/20/EC is no longer valid, but latest on 30.01.2025 (LPLV).
    A transition of this study to the new EU Clinical Trial Regulation 536/2014 is not intended.
    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 months2
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days16
    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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 440
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-03
    P. End of Trial
    P.End of Trial StatusOngoing
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