Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
108
Countries
1
Sites
22
High-risk Myelodysplastic neoplasia
Best CR/CRi/CRh during induction chemotherapy
Key facts
- Sponsor
- University of Leipzig
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- completed 8 Feb 2024
- Decision date (initial)
- 2023-07-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Best CR/CRi/CRh during induction chemotherapy
Secondary objectives 6
- Overall Survival
- Event Free Survival
- Relapse Free Survival
- Rate of allogeneic hematopoietic stem cell transplantation
- Quality of life
- Rate and severity of adverse events for patients treated with magrolimab and induction chemotherapy
Conditions and MedDRA coding
High-risk Myelodysplastic neoplasia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- AML or MDS-IB-2 according to WHO 2022 criteria
- “Intermediate or adverse risk” ELN 2022 category (for both MDS or AML)
- Intention to undergo intensive chemotherapy (CPX-351 or “7+3”) followed by allogeneic HSCT
Exclusion criteria 8
- Not eligible for intensive chemotherapy
- Any prior treatment for AML or high-risk MDS (including magrolimab) except hydoxyurea
- Harboring a FLT3mut, regardless of FLT3-ITD or FLT3-TKD mutation status
- Acute promyelocytic leukemia (APL)
- Inadequate cardiac, pulmonary, renal, hepatic function
- ECOG ≥3
- Active and uncontrolled infection
- Diagnosed or treated for another malignancy within 1 year before registration
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is CR/CRi/CRh at the end of induction therapy of a maximum of two induction cycles.
Secondary endpoints 6
- Overall Survival, OS, i.e. time from study inclusion until death from any cause
- Event Free Survival, EFS, i.e. time from study inclusion until non-achievement of a complete remission at the end of induction (after up to two induction chemotherapies), hematological relapse or death from any cause (whichever comes first)
- Relapse Free Survival, RFS, i.e. the time from achievement of complete remission until hematological relapse, or death from any cause (whichever comes first), only for patients achieving CR
- Rate of allogeneic hematopoietic stem cell transplantation
- Quality of life, QoL Impact of treatment assessed by using the validated questionnaires EORTC QLQ-C30 and EQ-5D-5L
- All AEs and SAEs during induction cycle 1, and possibly induction cycle 2, and consolidation cycles will be collected, CTC-graded, and MEDRA coded. Incidence proportions will be calculated.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD4932287 · Product
- Active substance
- HU5F9G4
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- GILEAD SCIENCES INC
- Paediatric formulation
- No
- Orphan designation
- No
Vyxeos Liposomal 44 mg/100 mg powder for concentrate for solution for infusion.
PRD6605639 · Product
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XY01 — -
- Marketing authorisation
- EU/1/18/1308/001
- MA holder
- JAZZ PHARMACEUTICALS IRELAND LTD
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Daunoblastin® 20 mg Pulver zur Herstellung einer Infusions- oder Injektionslösung
PRD4259174 · Product
- Active substance
- Daunorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 60 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01DB02 — DAUNORUBICIN
- Marketing authorisation
- 69540.00.00
- MA holder
- PFIZER PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cytarabin Accord 100 mg/ml Injektions-/Infusionslösung
PRD1167931 · Product
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/square meter
- Max total dose
- 1 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- 88149.00.00
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University of Leipzig
- Sponsor organisation
- University of Leipzig
- Address
- Härtelstraße 16-18, Zentrum-Süd Zentrum-Süd
- City
- Leipzig
- Postcode
- 04107
- Country
- Germany
Scientific contact point
- Organisation
- University of Leipzig
- Contact name
- Prof. Dr. Uwe Platzbecker
Public contact point
- Organisation
- University of Leipzig
- Contact name
- Prof. Dr. Uwe Platzbecker
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 108 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Gemeinschaftsklinikum Mittelrhein gGmbH
Klinik für Innere Medizin, Johannes-Müller-Str. 7, 56068, Koblenz
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Hämatologie, Onkologie, Stammzelltransplantation, Flemmingstrasse 2g, Altendorf, Chemnitz
Universitaetsklinikum Aachen AöR
Medizinische Klinik IV - Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Pauwelsstrasse 30, 52074, Aachen
University Hospital Jena KöR
Klinik und Poliklinik für Innere Medizin II/Hämat. -Onkologie, Am Klinikum 1, Lobeda, Jena
ELBLANDKLINIKEN Stiftung & Co. KG
Innere Medizin II - Hämatologie/Onkologie und Gastroenterologie, Weinbergstrasse 8, Altriesa, Riesa
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Kliniken Sindelfingen
Medizinische Klinik I - Hämatologie/ Onkologie, Arthur-Gruber-Straße 70, Germany, Sindelfingen
Technische Universitat Dresden
Hämatologie, Zelltherapie und Medizinische Onkologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Goethe University Frankfurt
Medizinische Klinik II, Abt. Hämatologie, med. Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
University Hospital Augsburg
Hämatologie/Internistische Onkologie, Stenglinstrasse 2, Kriegshaber, Augsburg
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Klinik für Onkologie und Hämatologie, Pruefeninger Strasse 86, Westenviertel, Regensburg
Westfaelische Wilhelms-Universitaet Muenster
Innere Medizin A/Hämatologie-Onkologie, Building A10, Albert-Schweitzer-Campus 1, Muenster
University Medical Centre Schleswig-Holstein
Klinik für Innere Medizin II/ Hämatologie und Onkologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Mannheim GmbH
III. Medizinische Klinik - Hämatologie und Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Heidelberg AöR
Innere Medizin V, Klinik für Hämatologie, Onkologie und Rheumatologie, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Helios Klinikum Berlin-Buch GmbH
Zentrum Hämatologie, Onkologie, Palliativmedizin, Schwanebecker Chaussee 50, Buch, Berlin
Robert Bosch Gesellschaft Fuer Medizinische Forschung mbH
Abteilung für Hämatologie, Onkologie und Palliativmedizin, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 5, Hämatologie und Internistische Onkologie, Ulmenweg 18, Innenstadt, Erlangen
Martin-Luther-Universitaet Halle-Wittenberg
Universitätsklinik und Poliklinik für Innere Medizin IV, Onkologie, Hämatologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Carl Thiem Klinikum gGmbH
2. Medizinischen Klinik für Hämatologie, Onkologie, Pneumologie & Nephrologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
Sozialstiftung Bamberg
Sozialstation Bamberg, Buger Strasse 80, Berg, Bamberg
Helios Klinikum Duisburg GmbH
Medizinische Klinik II Onkologie und Hämatologie, Dieselstrasse 185, 47166, Duisburg
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Cover Letter SUM-56304
|
2024-11-11T13:55:28 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary in local language | 2024-11-11T13:57:44 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | MAGROLIC_Lay person summary_GERMAN_2024-11-08 | 1 |
| Summary of results (for publication) | MAGROLIC_Cover_Letter_2024-11-08_p | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-29 | Germany | Acceptable 2023-07-17
|
2023-07-18 |