Clinical trial • Phase III • Oncology
TRETINOIN for Acute myeloid leukemia
Phase III trial of TRETINOIN for Acute myeloid leukemia.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 27-09-2024
- First CTIS Authorization Date
- 16-10-2024
Trial design
Randomised, atra (vesanoid 10 mg capsules; active substance tretinoin; max daily dose listed as 45 mg/m2) versus placebo (p-tabletten weiß 7 mm lichtenstein, optically identical capsules). both given as add-on to backbone treatment with decitabine (dac) and venetoclax (ven). detailed schedules for atra/dac/ven are not specified in the provided record.-controlled Phase III trial across 30 sites in Germany.
- Randomised
- Yes
- Comparator
- ATRA (Vesanoid 10 mg capsules; active substance tretinoin; max daily dose listed as 45 mg/m2) versus Placebo (P-Tabletten weiß 7 mm Lichtenstein, optically identical capsules). Both given as add-on to backbone treatment with decitabine (DAC) and venetoclax (VEN). Detailed schedules for ATRA/DAC/VEN are not specified in the provided record.
- Target Sample Size
- 256
Eligibility
Recruits 256 No vulnerable population selected. Patients without legal capacity are explicitly excluded. Written informed consent must be obtained according to international guidelines and local laws; ability to understand trial procedures is an inclusion requirement. No assent process for minors is provided (age ≥ 18 years required)..
- Pregnancy Exclusion
- Current or planned pregnancy, nursing period
- Vulnerable Population
- No vulnerable population selected. Patients without legal capacity are explicitly excluded. Written informed consent must be obtained according to international guidelines and local laws; ability to understand trial procedures is an inclusion requirement. No assent process for minors is provided (age ≥ 18 years required).
Inclusion criteria
- {"criterion_text":"-Age ≥ 18 years"}
- {"criterion_text":"-Previously untreated AML (WHO 2016)"}
- {"criterion_text":"-ECOG ≤ 2"}
- {"criterion_text":"-White blood cell count < 25×109/L (hydroxyurea or Ara-C are permitted to meet this criterion,"}
- {"criterion_text":"-Patients considered not to benefit from the induction therapy or whom standard induction chemotherapy is not feasible; the following criteria are accepted (example): -\tage ≥ 75 years -\t -\tECOG ≥ 1 -\t -\tHCT-CI ≥ 3 -\tadverse genetics -\t -\tpatient declines standard aggressive chemotherapy -\tmissing social support system"}
- {"criterion_text":"-Projected life expectancy of at least 8 weeks"}
- {"criterion_text":"-Written informed consent obtained according to international guidelines and local laws"}
- {"criterion_text":"-Ability to understand the nature, significance and consequences of the trial and the trial related procedures and to comply with them"}
Exclusion criteria
- {"criterion_text":"-Acute promyelocytic leukemia (APL, FAB M3)"}
- {"criterion_text":"-Known allergy against soy-beans or peanuts (due to ATRA excipients)"}
- {"criterion_text":"-Known hypersensitivity to or intolerance of one of the trial drugs or its constituents (e.g. other retinoids (ATRA) or sunset yellow FCF E110)"}
- {"criterion_text":"-Known rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption"}
- {"criterion_text":"-Any malignancy requiring chemotherapy for which the patient received chemotherapy within 3 months prior to randomization"}
- {"criterion_text":"-Participation in any other interventional clinical trial within the last 30 days before randomization"}
- {"criterion_text":"-Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed"}
- {"criterion_text":"-Patient without legal capacity"}
- {"criterion_text":"-Known or persistent abuse of medication, drugs or alcohol"}
- {"criterion_text":"-Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic"}
- {"criterion_text":"-Person who is in a relationship of dependence/employment with the sponsor or the investigator"}
- {"criterion_text":"-Previous treatment with DAC, azacitidine, or other DNA-hypomethylating agents, ATRA, venetoclax and other Bcl-2 inhibitors"}
- {"criterion_text":"-Current or planned pregnancy, nursing period"}
- {"criterion_text":"-For fertile patients: failure to use one of the following safe methods of contraception: intra-uterine device or hormonal contraception in combination with a mechanical method of contraception."}
- {"criterion_text":"-Previous allogeneic stem cell transplantation or solid organ transplantation"}
- {"criterion_text":"-Previous induction chemotherapy"}
- {"criterion_text":"-Previous low-dose chemotherapy (e.g. hydroxyurea, cytosine arabinoside (Ara-C), melphalan etc.) within 4 weeks prior to the first administration of study treatment, except for cytoreduction of leukocytosis ≥ 25,000/µl with hydroxyurea or Ara-C as proscribed prescribed by the clinical trial protocol; the patient must have recovered from all clinically relevant reversible non-hematologic toxicities"}
- {"criterion_text":"-Central nervous system (CNS) leukemia"}
- {"criterion_text":"-Severe congestive heart failure, clinically unstable cardiac disease or QTc prolongation ≥ CTCAE grade 3"}
- {"criterion_text":"-Known positivity for HIV, Hepatitis B or Hepatitis C"}
- {"criterion_text":"-Uncontrolled bacterial, viral or fungal infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Overall survival (OS) time","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"-Objective best response (CR, CRi, MLFS or PR)","definition_or_measurement_approach":""}
- {"endpoint_text":"-CR with negative MRD (CRMRD-)","definition_or_measurement_approach":""}
- {"endpoint_text":"-OS time with objective best response (CR, CRi, MLFS or PR)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Quality of life (EORTC QLQ-C30) (especially fatigue) and FACIT Fatigue Scale","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 and FACIT Fatigue Scale"}
Recruitment
- Planned Sample Size
- 256
- Recruitment Window Months
- 59
- Consent Approach
- Written informed consent required according to international guidelines and local laws. Inclusion requires ability to understand trial procedures. Subject information and informed consent form documents are provided (DE language versions listed in documents). No assent for minors (age ≥ 18 years).
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 256
Germany
- Latest Decision Or Authorization Date
- 06-05-2026
- Number Of Sites
- 30
- Number Of Participants
- 256
Sites
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- II. Medizinische Klinik
- Contact Person Name
- Bjoern Hackanson
- Contact Person Email
- bjoern.hackanson@uk-augsburg.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Klinik für Innere Medizin IV
- Contact Person Name
- Haifa Kathrin Al-Ali
- Contact Person Email
- haifa.al-ali@uk-halle.de
- Site Name
- Barmherzige Brueder Trier gGmbH
- Department Name
- Innere Medizin I
- Contact Person Name
- Iordanis Deligiannis
- Contact Person Email
- i.deligiannis@bbtgruppe.de
- Site Name
- Caritas Traegergesellschaft Saarbruecken mbH (CTS)
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Jerome Schwingel
- Contact Person Email
- j.schwingel@caritasklinikum.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
- Contact Person Name
- Felicitas Thol
- Contact Person Email
- thol.felicitas@mh-hannover.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
- Contact Person Name
- Martina Crysandt
- Contact Person Email
- mcrysandt@ukaachen.de
- Site Name
- Universitat Heidelberg
- Department Name
- Medizinische Klinik, Innere Medizin V
- Contact Person Name
- Tim Sauer
- Contact Person Email
- tim.sauer@med.uni-heidelberg.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Klinik für Hämatologie und Onkologie, Cancer Center Oldenburg
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- frank.griesinger@pius-hospital.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Medizinische Klinik und Poliklinik III
- Contact Person Name
- Lino Teichmann
- Contact Person Email
- lino.teichmann@ukbonn.de
- Site Name
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
- Department Name
- Klinik für Innere Medizin II
- Contact Person Name
- Paul La Rosée
- Contact Person Email
- paul.larosee@sbk-vs.de
- Site Name
- HELIOS Klinikum Berlin-Buch GmbH
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Contact Person Name
- Snjezana Janjetovic
- Contact Person Email
- Snjezana.Janjetovic@helios-gesundheit.de
- Site Name
- Augusta-Kranken-Anstalt gGmbH
- Department Name
- Klinik für Hämtologie, Onkologie und Palliativmedizin
- Contact Person Name
- Stefan Lukic
- Contact Person Email
- s.lukic@augusta-bochum.de
- Site Name
- Rostock University Medical Center
- Department Name
- Medizinische Klinik III
- Contact Person Name
- Christian Junghanss
- Contact Person Email
- christian.junghanss@med.uni-rostock.de
- Site Name
- Staedtisches Klinikum Braunschweig gGmbH
- Department Name
- Medizinische Klinik III
- Contact Person Name
- Juergen Krauter
- Contact Person Email
- j.krauter@klinikum-braunschweig.de
- Site Name
- Universitat Heidelberg (Mannheim)
- Department Name
- III. Medizinische Klinik Hämatologie und Onkologie
- Contact Person Name
- Jan Koch
- Contact Person Email
- jan.koch@umm.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Klinik für Hämatologie, Onkologie und Palliativmedizin
- Contact Person Name
- Maike de Wit
- Contact Person Email
- maike.dewit@vivantes.de
- Site Name
- St.-Antonius-Hospital gGmbH
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Peter Staib
- Contact Person Email
- peter.staib@sah-eschweiler.de
- Site Name
- Maerkische Kliniken GmbH
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Monika Schwalenberg
- Contact Person Email
- onkologie@klinikum-luedenscheid.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Lorenz Oelschläger
- Contact Person Email
- Lorenz.Oelschlaeger@uksh.de
- Site Name
- Ortenau Klinikum
- Department Name
- Onkologie
- Contact Person Name
- Oliver Schmah
- Contact Person Email
- oliver.schmah@ortenau-klinikum.de
- Site Name
- Staedtisches Klinikum Karlsruhe gGmbH
- Department Name
- Medizinische Klinik III
- Contact Person Name
- Lukas Kuendgen
- Contact Person Email
- lukas.kuendgen@klinikum-karlsruhe.de
- Site Name
- Klinikum Oldenburg AöR
- Department Name
- Universitätsklinik für Innere Medizin – Onkologie und Hämatologie
- Contact Person Name
- Cyrus Khandanpour
- Contact Person Email
- onkologie.ambulanz@klinikum-oldenburg.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Innere Medizin II
- Contact Person Name
- Ulf Schnetzke
- Contact Person Email
- ulf.schnetzke@med.uni-jena.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Hämatologie, Onkologie und klinische Immunologie
- Contact Person Name
- Ulrich Germing
- Contact Person Email
- germing@med.uni-duesseldorf.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin I
- Contact Person Name
- Michael Luebbert
- Contact Person Email
- michael.luebbert@uniklinik-freiburg.de
- Site Name
- Katholisches Krankenhaus Hagen gGmbH
- Department Name
- Klinik für Hämatologie und Onkologie
- Contact Person Name
- Doris Maria Kraemer
- Contact Person Email
- kraemerd@kkh-hagen.de
- Site Name
- Universitaet Muenster
- Department Name
- Medizinische Klinik A
- Contact Person Name
- Jan-Henrik Mikesch
- Contact Person Email
- jan-henrik.mikesch@ukmuenster.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin III
- Contact Person Name
- Hartmut Doehner
- Contact Person Email
- Hartmut.Doehner@uniklinik-ulm.de
- Site Name
- Klinikum Esslingen GmbH
- Department Name
- Klinik für Allgemeine Innere Medizin, Onkologie/Hämatologie, Gastroenterologie und Infektiologie
- Contact Person Name
- Swen Wessendorf
- Contact Person Email
- s.wessendorf@klinikum-esslingen.de
- Site Name
- Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch
- Department Name
- Klinik für Innere Medizin
- Contact Person Name
- Volker Runde
- Contact Person Email
- volker.runde@kkle.de
Sponsor
Primary sponsor
- Full Name
- Medical Center - University Of Freiburg
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR","duties_or_roles":"Manufacturing of IMP","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Medical Center - University Of Freiburg","duties_or_roles":"1,10,11,5,6,8","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"4","organisation_type":"Educational Institution"}
- {"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Vesanoid 10 mg Kapseln
- Active Substance
- TRETINOIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation information present (marketingAuthNumber: 1-21707, authorisationCountryCode: AT)
- Maximum Dose
- 45 mg/m2 (max daily dose amount)
- Investigational Product Name
- P-Tabletten weiß 7 mm Lichtenstein
- Active Substance
- PLACEBO
- Modality
- Other
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Marketing authorisation information present (marketingAuthNumber: 6866372.00.00, authorisationCountryCode: DE)
- Maximum Dose
- 0 mg (max daily dose amount)
- Combination Treatment
- Yes
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