Clinical trial • Not applicable • Oncology|Haematology

DAUNORUBICIN HYDROCHLORIDE for Acute myeloid leukemia|Relapsed or refractory acute myeloid leukemia

Not applicable trial of DAUNORUBICIN HYDROCHLORIDE for Acute myeloid leukemia|Relapsed or refractory acute myeloid leukemia.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Acute myeloid leukemia|Relapsed or refractory acute myeloid leukemia
Trial Stage
Not applicable
Drug Modality
Small molecule|ADC
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
01-08-2024
First CTIS Authorization Date
27-11-2024

Trial design

Randomised, comparator options (as listed in part i/product role groups): daunorubicin — max daily dose 90 mg/m2 (intravenous infusion); idarubicin — max daily dose 14 mg/m2 (intravenous infusion); amsacrine — max daily dose 125 mg/m2 (intravenous infusion); cytarabine — comparator formulations indicated (e.g. 6 g total, route injection); mitoxantrone — max daily dose 12 mg/m2 (intravenous infusion); fludarabine — max daily dose 30 mg/m2 (intravenous infusion); etoposide — max daily dose 100 mg/m2 (intravenous infusion). schedules are per local standard of care/smpc; specific administration schedules not specified in the ctis part i data.-controlled Not applicable trial in Portugal, Romania, Germany and others.

Randomised
Yes
Comparator
Comparator options (as listed in Part I/Product role groups): DAUNORUBICIN — max daily dose 90 mg/m2 (intravenous infusion); IDARUBICIN — max daily dose 14 mg/m2 (intravenous infusion); AMSACRINE — max daily dose 125 mg/m2 (intravenous infusion); CYTARABINE — comparator formulations indicated (e.g. 6 g total, route injection); MITOXANTRONE — max daily dose 12 mg/m2 (intravenous infusion); FLUDARABINE — max daily dose 30 mg/m2 (intravenous infusion); ETOPOSIDE — max daily dose 100 mg/m2 (intravenous infusion). Schedules are per local standard of care/SmPC; specific administration schedules not specified in the CTIS Part I data.
Target Sample Size
267
Trial Duration For Participant
1095

Eligibility

Recruits 267 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be willing and able to give informed consent themselves (inclusion criterion). Minors excluded (Male or Female, aged>18 years). Country-specific ICFs and privacy/biobank information documents are provided (see country ICF documents)..

Pregnancy Exclusion
A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be willing and able to give informed consent themselves (inclusion criterion). Minors excluded (Male or Female, aged>18 years). Country-specific ICFs and privacy/biobank information documents are provided (see country ICF documents).

Inclusion criteria

  • {"criterion_text":"- Non-APL AML defined according WHO 2022 (or ICC 2022) criteria\n- 1st or 2nd relapse or refractory according to ELN 2022\n- Patient is clinically candidate both to low intensity therapy and to high dose chemotherapy in the opinion of the physician\n- Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice\n- No specific treatment protocol can be rationally considered better suited to patient needs. This specifically include, but is not limited to i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization\n- Male or Female, aged>18 years\n- ECOG performance status <4\n- A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.\n- Participant is willing and able to give informed consent for participation in the study"}

Exclusion criteria

  • {"criterion_text":"- Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of SmPC (e.g. hypersensitivity, allergy, organ failure precluding treatment)\n- Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization.\n- Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first","definition_or_measurement_approach":"Event-free survival measured as time from randomization to treatment failure, hematologic relapse from CR/CRh/CRi (or CRh/CRi) or death from any cause, whichever occurs first (time-to-event endpoint as defined in protocol)."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival, defined as time from randomization to the date of death from any cause","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause (time-to-event)."}
  • {"endpoint_text":"- Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort","definition_or_measurement_approach":"Overall response rate assessed as best response during study treatment using categories CR, CRh, CRi, MLFS."}
  • {"endpoint_text":"- Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.","definition_or_measurement_approach":"Patient-reported outcome measured by HM-PRO A-total score; change from screening to end of treatment assessment according to HM-PRO questionnaire scoring."}
  • {"endpoint_text":"- Proportion of patients experiencing adverse events","definition_or_measurement_approach":"Safety endpoint measured as proportion of patients experiencing adverse events (AE reporting per protocol)."}

Recruitment

Registry Or Advocacy Recruitment
True, Czech Leukemia Study Group - for Life|Fondazione Gimema Franco Mandelli Onlus|Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V.|IIS La Fe
Planned Sample Size
267
Recruitment Window Months
36
Consent Approach
Informed consent must be provided by the participant (inclusion criterion: participant is willing and able to give informed consent). Participants are adults (>18 years). Subject information and informed consent forms are provided per country (documents available for publication in multiple languages including Italian, English, Portuguese, Romanian, German, Lithuanian, Spanish, Czech) and separate ICFs for biobank/privacy are provided where applicable.

Geography

Total Number Of Sites
44
Total Number Of Participants
267

Portugal

Earliest CTIS Part Ii Submission Date
20-03-2025
Latest Decision Or Authorization Date
12-05-2025
Processing Time Days
53
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Hospital De Santa Maria E.P.E.
Department Name
Hematology
Principal Investigator Name
Joana Brioso Infante
Principal Investigator Email
joanabrioso@gmail.com
Contact Person Name
Joana Brioso Infante
Contact Person Email
joanabrioso@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
16-06-2025
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
7
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Hematology
Principal Investigator Name
Daniel Coriu
Principal Investigator Email
daniel_coriu@yahoo.com
Contact Person Name
Daniel Coriu
Contact Person Email
daniel_coriu@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
27-11-2024
Processing Time Days
30
Number Of Sites
6
Number Of Participants
50

Sites

Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Universitätsmedizin Greifswald Klinik für Innere Medizin C, Hämatologie und Onkologie
Principal Investigator Name
Adrian Schwarzer
Principal Investigator Email
adrian.schwarzer@med.uni-greifswald.de
Contact Person Name
Adrian Schwarzer
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Innere Medizin IV (Hämatologie und Onkologie)
Principal Investigator Name
Judith Schaffrath
Principal Investigator Email
innere4@uk-halle.de
Contact Person Name
Judith Schaffrath
Contact Person Email
innere4@uk-halle.de
Site Name
Heinrich-Braun-Klinikum Zwickau gGmbH
Department Name
Internal Medicine
Principal Investigator Name
Sara Hilber
Principal Investigator Email
sara.hilber@hbk-zwickau.de
Contact Person Name
Sara Hilber
Contact Person Email
sara.hilber@hbk-zwickau.de
Site Name
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Department Name
Internal Medicine
Principal Investigator Name
Kinga Ligeti
Principal Investigator Email
kinga.ligeti@krankenhaus-halle-saale.de
Contact Person Name
Kinga Ligeti
Site Name
Rostock University Medical Center
Department Name
Innere Medizin, Hämatologie
Principal Investigator Name
Christian Junghanß
Principal Investigator Email
christian.junghanss@med.uni-rostock.de
Contact Person Name
Christian Junghanß
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzell transplantation
Principal Investigator Name
Martina Crysandt
Principal Investigator Email
mcrysandt@ukaachen.de
Contact Person Name
Martina Crysandt
Contact Person Email
mcrysandt@ukaachen.de

Lithuania

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
28-11-2024
Processing Time Days
48
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Hematology
Principal Investigator Name
Rolandas Gerbutavičius
Principal Investigator Email
Rolandas.Gerbutavicius@kaunoklinikos.lt
Contact Person Name
Rolandas Gerbutavičius

Italy

Earliest CTIS Part Ii Submission Date
12-11-2024
Latest Decision Or Authorization Date
27-11-2024
Processing Time Days
15
Number Of Sites
22
Number Of Participants
120

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ematologia
Principal Investigator Name
Nicola Stefano Fracchiolla
Principal Investigator Email
nicola.fracchiolla@policlinico.mi.it
Contact Person Name
Nicola Stefano Fracchiolla
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Dept of Clinical and Biological Sciences
Principal Investigator Name
Daniela Cilloni
Principal Investigator Email
daniela.cilloni@unito.it
Contact Person Name
Daniela Cilloni
Contact Person Email
daniela.cilloni@unito.it
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Hematology
Principal Investigator Name
Lara Pochintesta
Principal Investigator Email
L.Pochintesta@ausl.pc.it
Contact Person Name
Lara Pochintesta
Contact Person Email
L.Pochintesta@ausl.pc.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Hematology
Principal Investigator Name
Erika Borlenghi
Principal Investigator Email
erika.borlenghi@gmail.com
Contact Person Name
Erika Borlenghi
Contact Person Email
erika.borlenghi@gmail.com
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
ONCOEMATOLOGIA
Principal Investigator Name
Antonino Mulè
Principal Investigator Email
a.mule@villasofia.it
Contact Person Name
Antonino Mulè
Contact Person Email
a.mule@villasofia.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Experimental and Clinical medicine
Principal Investigator Name
Francesco Mannelli
Principal Investigator Email
francesco.mannelli@unifi.it
Contact Person Name
Francesco Mannelli
Contact Person Email
francesco.mannelli@unifi.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Hematology
Principal Investigator Name
Patrizia Zappasodi
Principal Investigator Email
p.zappasodi@smatteo.pv.it
Contact Person Name
Patrizia Zappasodi
Contact Person Email
p.zappasodi@smatteo.pv.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Ematologia
Principal Investigator Name
Federica Lessi
Principal Investigator Email
federica.lessi@unipd.it
Contact Person Name
Federica Lessi
Contact Person Email
federica.lessi@unipd.it
Site Name
Azienda Socio Sanitaria Territoriale Della Valle Olona
Department Name
Oncologia
Principal Investigator Name
Elisabetta Todisco
Principal Investigator Email
elisabetta.todisco@asst-valleolona.it
Contact Person Name
Elisabetta Todisco
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
Oncologia
Principal Investigator Name
Davide Facchinelli
Principal Investigator Email
davide.facchinelli@aulss8.veneto.it
Contact Person Name
Davide Facchinelli
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
Hematology
Principal Investigator Name
Monica Bocchia
Principal Investigator Email
bocchia@unisi.it
Contact Person Name
Monica Bocchia
Contact Person Email
bocchia@unisi.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Hematology
Principal Investigator Name
Valentina Mancini
Principal Investigator Email
valentina.mancini@ospedaleniguarda.it
Contact Person Name
Valentina Mancini
Site Name
Casa Sollievo Della Sofferenza
Department Name
Hematology
Principal Investigator Name
Giovanni Rossi
Principal Investigator Email
giovannirossi.fr@gmail.com
Contact Person Name
Giovanni Rossi
Contact Person Email
giovannirossi.fr@gmail.com
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ematologia
Principal Investigator Name
Anna Maria Mianulli
Principal Investigator Email
annamaria.mianulli@auslromagna.it
Contact Person Name
Anna Maria Mianulli
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Hematology
Principal Investigator Name
Antonio Curti
Principal Investigator Email
antonio.curti2@unibo.it
Contact Person Name
Antonio Curti
Contact Person Email
antonio.curti2@unibo.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Haematology and Oncology
Principal Investigator Name
Ernesta Audisio
Principal Investigator Email
eaudisio@cittadellasalute.to.it
Contact Person Name
Ernesta Audisio
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Hematology
Principal Investigator Name
Saveria Capria
Principal Investigator Email
capria@bce.uniroma1.it
Contact Person Name
Saveria Capria
Contact Person Email
capria@bce.uniroma1.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Medicina e chirurgia
Principal Investigator Name
Maria Paola Martelli
Principal Investigator Email
maria.martelli@unipg.it
Contact Person Name
Maria Paola Martelli
Contact Person Email
maria.martelli@unipg.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Hematology
Principal Investigator Name
Mario Annunziata
Principal Investigator Email
mario.annunziata@aocardarelli.it
Contact Person Name
Mario Annunziata
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
Oncologico-ematologico, UOC Ematologia
Principal Investigator Name
Prassede Salutari
Principal Investigator Email
prassede.salutari@asl.pe.it
Contact Person Name
Prassede Salutari
Contact Person Email
prassede.salutari@asl.pe.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica Ematologica, Dipartimento di Medicina Interna
Principal Investigator Name
Fabio Guolo
Principal Investigator Email
fabio.guolo@unige.it
Contact Person Name
Fabio Guolo
Contact Person Email
fabio.guolo@unige.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncohematology
Principal Investigator Name
Maria Benedetta Giannini
Principal Investigator Email
maria.giannini@irst.emr.it
Contact Person Name
Maria Benedetta Giannini
Contact Person Email
maria.giannini@irst.emr.it

Spain

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
28
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Principal Investigator Name
Pau Montesinos
Principal Investigator Email
montesinos_pau@gva.es
Contact Person Name
Pau Montesinos
Contact Person Email
montesinos_pau@gva.es
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Hematology
Principal Investigator Name
Armando Mena Duran
Principal Investigator Email
mena_arm@gva.es
Contact Person Name
Armando Mena Duran
Contact Person Email
mena_arm@gva.es
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Hematology
Principal Investigator Name
Carmen Botella Prieto
Principal Investigator Email
carmenbotellaprieto@gmail.com
Contact Person Name
Carmen Botella Prieto
Contact Person Email
carmenbotellaprieto@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Olga Salamero
Principal Investigator Email
osalamero@vhio.net
Contact Person Name
Olga Salamero
Contact Person Email
osalamero@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Hematology
Principal Investigator Name
María del Mar Tormo Díaz
Principal Investigator Email
tormo_mar@gva.es
Contact Person Name
María del Mar Tormo Díaz
Contact Person Email
tormo_mar@gva.es
Site Name
Hospital General Universitario De Albacete
Department Name
Hematology
Principal Investigator Name
Jesús Lorenzo Algarra
Principal Investigator Email
hemato78@hotmail.com
Contact Person Name
Jesús Lorenzo Algarra
Contact Person Email
hemato78@hotmail.com
Site Name
Hospital General Universitario De Albacete (additional site entry)
Department Name
Hematology
Principal Investigator Name
Jesús Lorenzo Algarra
Principal Investigator Email
hemato78@hotmail.com
Contact Person Name
Jesús Lorenzo Algarra
Contact Person Email
hemato78@hotmail.com

Czechia

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
28-11-2024
Processing Time Days
31
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Hematology
Principal Investigator Name
Jan Novák
Principal Investigator Email
jan.novak@fnkv.cz
Contact Person Name
Jan Novák
Contact Person Email
jan.novak@fnkv.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Haematology and Oncology
Principal Investigator Name
Pavel Jindra
Principal Investigator Email
jindra@fnplzen.cz
Contact Person Name
Pavel Jindra
Contact Person Email
jindra@fnplzen.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Internal Medicine, Hematology and Oncology
Principal Investigator Name
Jiri Mayer
Principal Investigator Email
mayer.jiri@fnbrno.cz
Contact Person Name
Jiri Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Haematooncology
Principal Investigator Name
Zdenek Koristek
Principal Investigator Email
zdenek.koristek@fno.cz
Contact Person Name
Zdenek Koristek
Contact Person Email
zdenek.koristek@fno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Hematology
Principal Investigator Name
Pavel Zak
Principal Investigator Email
pavel.zak@fnhk.cz
Contact Person Name
Pavel Zak
Contact Person Email
pavel.zak@fnhk.cz
Site Name
Fakultni Nemocnice Olomouc
Department Name
Department of Haemato-oncology
Principal Investigator Name
Tomas Szotkowski
Principal Investigator Email
tomas.szotkowski@fnol.cz
Contact Person Name
Tomas Szotkowski
Contact Person Email
tomas.szotkowski@fnol.cz

Sponsor

Primary sponsor

Full Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Third parties

  • {"country":"Czechia","full_name":"Czech Leukemia Study Group - for Life","duties_or_roles":"1,12,2,5","organisation_type":"Health care"}
  • {"country":"Italy","full_name":"Fondazione Gimema Franco Mandelli Onlus","duties_or_roles":"1,12,2,5","organisation_type":"Patient organisation/association"}
  • {"country":"Germany","full_name":"Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V.","duties_or_roles":"1,12,2,5","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"IIS La Fe","duties_or_roles":"1,12,2,5","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
GLASDEGIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Orphan Designation
Yes
Maximum Dose
100 mg
Investigational Product Name
DAUNORUBICIN
Active Substance
DAUNORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
-
Maximum Dose
90 mg/m2
Investigational Product Name
AZACITIDINE
Active Substance
AZACITIDINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Route
INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
Authorisation Status
-
Maximum Dose
75 mg/m2
Investigational Product Name
AMSACRINE
Active Substance
AMSACRINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
-
Maximum Dose
125 mg/m2 (daily), max total 750 mg/m2
Investigational Product Name
CYTARABINE
Active Substance
CYTARABINE
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
-
Maximum Dose
40 mg/m2 (where indicated) or 6 g (in other comparator entry) — see product entry
Investigational Product Name
DECITABINE
Active Substance
DECITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
-
Orphan Designation
Yes
Maximum Dose
20 mg/m2
Investigational Product Name
FLUDARABINE
Active Substance
FLUDARABINE PHOSPHATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
-
Maximum Dose
30 mg/m2
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
-
Maximum Dose
100 mg/m2
Investigational Product Name
GILTERITINIB
Active Substance
GILTERITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Orphan Designation
Yes
Maximum Dose
200 mg
Investigational Product Name
IDARUBICIN
Active Substance
IDARUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
-
Maximum Dose
14 mg/m2
Investigational Product Name
VENETOCLAX
Active Substance
VENETOCLAX
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Maximum Dose
400 mg
Investigational Product Name
MITOXANTRONE
Active Substance
MITOXANTRONE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
-
Maximum Dose
12 mg/m2
Investigational Product Name
IVOSIDENIB
Active Substance
IVOSIDENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Orphan Designation
Yes
Maximum Dose
500 mg
Investigational Product Name
CLADRIBINE
Active Substance
CLADRIBINE
Modality
Small molecule
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
-
Maximum Dose
5 mg/m2
Investigational Product Name
GEMTUZUMAB OZOGAMICIN
Active Substance
GEMTUZUMAB OZOGAMICIN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
-
Orphan Designation
Yes
Maximum Dose
3 mg/m2 (max total 5 mg reported)

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