Acute Promyelocytic LeukemiaPhase 2NCT04793919
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
A Phase 2 study testing Mylotarg, Arsenic Trioxide and All-trans retinoic acid in people with Acute Promyelocytic Leukemia, run by Associazione Italiana Ematologia Oncologia Pediatrica at 31 sites in 12 countries.
Trial summary
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Promyelocytic Leukemia
- What is being tested?
- Mylotarg, Arsenic Trioxide and All-trans retinoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 31 sitesin 12 countries
- Study dates
- 9 Oct 2019to 10 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age <18 years
- Written informed consent by parents or legal guardians
Who cannot join
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
- Significant liver dysfunction (bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- Creatinine serum levels >2 times the normal value for age
- Significant arrhythmias, EKG abnormalities (*see below), other cardiac contraindications (L-FEV <50% or LV-FS <28%)
- Neuropathy
- Concurrent active malignancy
Show all 9Show fewer
- Uncontrolled life-threatening infections
- Pregnant or lactating female
- Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available
Trial locations and contacts
31 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 12 countries
Italy18 sites, 18 recruiting
- Not yet recruiting
AOU Policlinico Dipartimento di Pediatria
Bari, 70124
- Not yet recruiting
Ospedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica
Bergamo, 24100
Massimo Provenzi, Dr
- Recruiting
AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica
Bologna, 40138
Andrea Pession, Prof
- Recruiting
Ospedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione
Cagliari, 09121
Rosamaria Mura, Dr
- Recruiting
AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO
Catania, 95123
Luca Lo Nigro, Dr
- Not yet recruiting
A.O. Universitaria Meyer - DAI Oncoematologia Pediatrica
Florence, 50139
Tommaso Casini, Dr
- Recruiting
IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia
Genova, 16147
Concetta Micalizzi, Dr
- Recruiting
Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo
Monza, 20900
Carmelo Rizzari, Dr
- Recruiting
AORN Santobono-Pausilipon
Naples, 80123
Giuseppe Menna, Dr
- Recruiting
Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica
Naples, 80138
Francesca Rossi, Prof
- Not yet recruiting
Azienda Ospedaliera di Padova - Oncoematologia Pediatrica
Padova, 35128
Alessandra Biffi, Prof
- Not yet recruiting
ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica
Palermo, 90127
Paolo D'Angelo, Dr
- Recruiting
Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica
Pavia, 27100
Marco Zecca, Dr
- Not yet recruiting
Ospedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica
Pisa, 56126
Gabriella Casazza, Dr
- Not yet recruiting
Policlinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica
Roma, 00161
Anna Maria Testi, Dr
- Recruiting
Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù"
Roma, 00165
Valentina Cirillo, Dr
Franco Locatelli, Prof
- Recruiting
Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica
San Giovanni Rotondo, Foggia, 71013
Saverio Ladogana, Dr
- Recruiting
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Torino, 10126
Franca Fagioli, Prof
Portugal3 sites, 3 recruiting
- Not yet recruiting
Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra
Coimbra, 3000-602
Manuel Brito, Dr.
- Not yet recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023
Ximo Duarte, Dr.
- Not yet recruiting
Instituto Português de Oncologia do Porto Francisco Gentil, E. P. E.
Porto, 4200-072
Vítor Costa, Dr.
Belgium1 site, 1 recruiting
- Not yet recruiting
Hôpital Universitaire des Enfants Reine Fabiola (Huderf)
Brussels, 1020
Laurence Dedeken, MD, +324772678, laurence.dedeken@huderf.be
Czechia1 site, 1 recruiting
- Not yet recruiting
University Hospital Motol
Prague, 15006
Lucie Sramkova, MD, 22443 6401 ext. +420, lucie.sramkova@fnmotol.cz
Denmark1 site, 1 recruiting
- Not yet recruiting
Pediatrics and Adolescent Medicine Aarhus University Hospital
Aarhus N, 8200
Henrik Hasle, Prof.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - Hôpital des Enfants
Bordeaux, 33076
Stéphane Ducassou, MD PhD, 0557820440, stephane.ducassou@chu-bordeaux.fr
Aurore Capelli, 0557820877, aurore.capelli@chu-bordeaux.fr
Germany1 site, 1 recruiting
- Not yet recruiting
Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III
Essen, 45147
Dirk Reinhardt, Prof, 49-(0)201 1723-3784, Dirk.Reinhardt@uk-essen.de
Ireland1 site, 1 recruiting
- Not yet recruiting
Our Lady's Children's Hospital Crumlin
Dublin, 12
Owen P. Smith, Prof, 003531-4096720, owen.smith@olchc.ie
Israel1 site, 1 recruiting
- Not yet recruiting
Rappaport Children'S Hospital, Rambam Health Care Campus
Haifa
NIRA ARAD-COHEN, MD, +972-50-206-1181, n_arad-cohen@rambam.health.gov.il
Netherlands1 site, 1 recruiting
- Not yet recruiting
VU medisch centrum
Amsterdam
Gertjan Kasper, Prof. dr.
Spain1 site, 1 recruiting
- Not yet recruiting
Valencia University Medical School University Hospital La Fe
Valencia, 46026
Miguel A. Sanz, MD, domingo_joa@gva.es
Sweden1 site, 1 recruiting
- Not yet recruiting
Childrens hematology and oncology Uppsala University
Uppsala, .O. Box 256, SE-751 05
Josefine Palle, MD, josefine.palle@akademiska.se
About this study
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
Read the detailed description
Acute promyelocytic leukemia (APL) in children has become a highly curable disease with the combination of all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy with an overall remission rates equal to or higher than 98% and cure rates now exceeding 80% 1-9.
Based on data coming from adults indicating that at least standard-risk APL patients may be cured without chemotherapy (i.e., with a treatment combining arsenic trioxide (ATO) and ATRA only) 10-12, this ICC APL 02 study was designed with the aim of validating the efficacy of a treatment combining:
- ATO and ATRA in newly diagnosed APL standard-risk (SR) children and adolescents and
- ATO, ATRA and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk (HR) children and adolescents.
Following one induction course of treatment combining ATO and ATRA +/- GO depending on risk stratification, patients will receive 4 ATO/ATRA based consolidation blocks. This is the first pediatric trial delivering a non-chemotherapy-based treatment for children with APL, being the whole treatment based on the use of ATRA, ATO (and GO in HR patients). The aim of the study is to demonstrate at least an equivalent efficacy and safety of this treatment not containing cytostatic agents compared to the standard protocols combining ATRA and chemotherapy (i.e. ICC APL Study 01).
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
This will be an international study, comprising the most important pediatric European groups, expecting to recruit 46 and 43 patients in SR and HR arms, respectively, in 3 years. The duration of study recruitment will be 36 months with a minimum follow-up per patient of 2 years.
The evaluation of morphological CR will be carried out after induction therapy, prior to the first block of consolidation therapy. MRD results after induction will not have an impact on subsequent therapy. By contrast, MRD results after the third consolidation course will influence the subsequent treatment, MRD-positive patients being eligible to rescue treatment, including hematopoietic stem cell transplantation (HSCT). BM aspirates will be repeated after the end of therapy, and 3 months, 6 months, 9 months and 12 months after treatment discontinuation.
This is a collaborative international study in APL in children and adolescents aimed at providing information about procedures for the entry, treatment and follow-up of pediatric patients with APL. It is not intended that this document be used as an aide-memoir or guide for the treatment of other patients. Every care has been taken in its drafting, but corrections and amendments may be necessary. Before entering patients into the study, clinicians must ensure that the study has received clearance from their Local Research Ethics Committee and any other necessary body.
- Conditions
- Acute Promyelocytic Leukemia
- Being tested
- Mylotarg, Arsenic Trioxide, All-trans retinoic acid
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MylotargDrug
Also called GO
See the protocol
Arsenic TrioxideDrug
Also called ATO
See the protocol
All-trans retinoic acidDrug
Also called ATRA
See the protocol
| Study group | Role | What they receive |
|---|---|---|
| Standard Risk (SR) | Active comparator | Patient with APL and WBC less than 10x10e9/L at presentation before start treatment Receives: Drug: Arsenic Trioxide; Drug: All-trans retinoic acid |
| High Risk (HR) | Experimental | Patient with APL, with the highest pre-treatment WBC count equal to or greater than 10x10e9/L at presentation Receives: Drug: Mylotarg; Drug: Arsenic Trioxide; Drug: All-trans retinoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS) probability
SR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) in newly diagnosed APL standard-risk children and adolescents HR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO), all-trans retinoic acid (ATRA) and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk children and adolescents
Measured: 3 years
Secondary outcomes (10)
Rate of hematological CR/CRi after induction
To evaluate the rate of hematological Complete Remission (CR) (defined as bone marrow regenerating normal hematopoietic cells and containing < 5% blast cells by morphology, with ANC in peripheral blood > 1.0 x 10^9/L and platelet count > 100 x 10^9/L) and Complete Remission with incomplete hematologic recovery (CRi) (defined as CR except that peripheral blood neutrophils and/or platelets do not meet the criteria as defined above) after induction therapy.
Measured: 5 years
Rate of molecular CR/CRi after induction
To evaluate the rate of molecular CR/CRi (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10^-4).
Measured: 5 years
Rate of early death during induction
To evaluate the rate of early death during induction (defined as any death occurring within 14 days from diagnosis from any cause).
Measured: 5 years
Probability of overall survival (OS) at 3 years
To evaluate the rate of overall survival
Measured: 3 years
Cumulative incidence of relapse (CIR) at 3 years
To evaluate the cumulative incidence of hematological relapse (defined as reappearance of promyeloblasts/abnormal promyelocytes > 5% in the bone marrow) and molecular relapse (defined as reappearance of PML/RARα fusion transcript in two successive samples taken at least 2 weeks apart in patients previously in molecular remission).
Measured: 3 years
Incidence of hematological and non-hematological toxicity
Incidence of treatment-related hematological and non-hematological toxicity assessed by CTCAE v4.0
Measured: 5 years
Rate of molecular remission after 3 consolidation cycles
To evaluate the rate of molecular remission (defined as the absence of PML/RARα fusion transcript in bone marrow assessed by RQ-PCR, with an assay sensitivity of at least 10^-4) after 3 consolidation cycles.
Measured: 5 years
Assessment of PML/RARα transcription level reduction during treatment
To evaluate the reduction of PML/RARα fusion transcript in bone marrow by means of RQ-PCR during treatment.
Measured: 5 years
Pediatric Quality of Life assessment
Pediatric Quality of life assessed by PedsQoL questionnaire, in the questionnaire there is a list of things that might be a problem for the child. The minimum value is 0 (never a problem) - maximum value 4 (almost always problem)
Measured: 5 years
Total hospitalization days during therapy
Number of total hospitalization days during the treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start9 Oct 2019
- Primary completion9 Oct 2025 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Italiana Ematologia Oncologia Pediatrica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanco Locatelli, Prof, Principal investigator, Dept. of Pediatric Hematology Oncology - Bambino Gesù Children's Hospital Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793919
- Sponsor's protocol ID
- ICC APL STUDY 02
- Other IDs
- 2017-002383-40, 2017
- Status last verified
- Apr 2024
- First submitted
- 13 Nov 2019
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
- ClinicalTrials.gov ID
- NCT04793919
- Acronym / sponsor ID
- ICC APL STUDY 02
- Conditions
- Acute Promyelocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Associazione Italiana Ematologia Oncologia PediatricaUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 9 Oct 2025 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
Detailed description
Acute promyelocytic leukemia (APL) in children has become a highly curable disease with the combination of all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy with an overall remission rates equal to or higher than 98% and cure rates now exceeding 80% 1-9.
Based on data coming from adults indicating that at least standard-risk APL patients may be cured without chemotherapy (i.e., with a treatment combining arsenic trioxide (ATO) and ATRA only) 10-12, this ICC APL 02 study was designed with the aim of validating the efficacy of a treatment combining:
- ATO and ATRA in newly diagnosed APL standard-risk (SR) children and adolescents and
- ATO, ATRA and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk (HR) children and adolescents.
Following one induction course of treatment combining ATO and ATRA +/- GO depending on risk stratification, patients will receive 4 ATO/ATRA based consolidation blocks. This is the first pediatric trial delivering a non-chemotherapy-based treatment for children with APL, being the whole treatment based on the use of ATRA, ATO (and GO in HR patients). The aim of the study is to demonstrate at least an equivalent efficacy and safety of this treatment not containing cytostatic agents compared to the standard protocols combining ATRA and chemotherapy (i.e. ICC APL Study 01).
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
This will be an international study, comprising the most important pediatric European groups, expecting to recruit 46 and 43 patients in SR and HR arms, respectively, in 3 years. The duration of study recruitment will be 36 months with a minimum follow-up per patient of 2 years.
The evaluation of morphological CR will be carried out after induction therapy, prior to the first block of consolidation therapy. MRD results after induction will not have an impact on subsequent therapy. By contrast, MRD results after the third consolidation course will influence the subsequent treatment, MRD-positive patients being eligible to rescue treatment, including hematopoietic stem cell transplantation (HSCT). BM aspirates will be repeated after the end of therapy, and 3 months, 6 months, 9 months and 12 months after treatment discontinuation.
This is a collaborative international study in APL in children and adolescents aimed at providing information about procedures for the entry, treatment and follow-up of pediatric patients with APL. It is not intended that this document be used as an aide-memoir or guide for the treatment of other patients. Every care has been taken in its drafting, but corrections and amendments may be necessary. Before entering patients into the study, clinicians must ensure that the study has received clearance from their Local Research Ethics Committee and any other necessary body.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Risk (SR) | Active comparator | Drug: Arsenic Trioxide, Drug: All-trans retinoic acidPatient with APL and WBC less than 10x10e9/L at presentation before start treatment |
| High Risk (HR) | Experimental | Drug: Mylotarg, Drug: Arsenic Trioxide, Drug: All-trans retinoic acidPatient with APL, with the highest pre-treatment WBC count equal to or greater than 10x10e9/L at presentation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age <18 years
- Written informed consent by parents or legal guardians
Key exclusion criteria (9 listed)
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
- Significant liver dysfunction (bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- Creatinine serum levels >2 times the normal value for age
- Significant arrhythmias, EKG abnormalities (*see below), other cardiac contraindications (L-FEV <50% or LV-FS <28%)
- Neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MylotargAlso: GOSee the protocol | Drug | High Risk (HR) |
| Arsenic TrioxideAlso: ATOSee the protocol | Drug | High Risk (HR), Standard Risk (SR) |
| All-trans retinoic acidAlso: ATRASee the protocol | Drug | High Risk (HR), Standard Risk (SR) |
Primary outcome
Event Free Survival (EFS) probability
Time frame: 3 years
SR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) in newly diagnosed APL standard-risk children and adolescents HR patients: To evaluate the efficacy in terms of event-free survival of a treatment combining arsenic trioxide (ATO), all-trans retinoic acid (ATRA) and gemtuzumab ozogamicin (GO) in newly diagnosed APL high-risk children and adolescents
10 secondary outcomes
Rate of hematological CR/CRi after induction
Time frame: 5 years
Rate of molecular CR/CRi after induction
Time frame: 5 years
Rate of early death during induction
Time frame: 5 years
Probability of overall survival (OS) at 3 years
Time frame: 3 years
Cumulative incidence of relapse (CIR) at 3 years
Time frame: 3 years
Incidence of hematological and non-hematological toxicity
Time frame: 5 years
Rate of molecular remission after 3 consolidation cycles
Time frame: 5 years
Assessment of PML/RARα transcription level reduction during treatment
Time frame: 5 years
Pediatric Quality of Life assessment
Time frame: 5 years
Total hospitalization days during therapy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fanco Locatelli, Prof principal investigator
Dept. of Pediatric Hematology Oncology - Bambino Gesù Children's Hospital Rome
31 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mylotarg, Arsenic Trioxide and All-trans retinoic acid in people with Acute Promyelocytic Leukemia, run by Associazione Italiana Ematologia Oncologia Pediatrica at 31 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy, Portugal, Belgium, Czechia, Denmark and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AIEOP (0039 051 2144667, studiclinici@aieop.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (EFS) probability (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.