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Latin American Real-world Study in Acute Leukemia

Completed
Conditions
Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Registration Number
NCT05166135
Lead Sponsor
Pfizer
Brief Summary

The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.

Detailed Description

This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
589
Inclusion Criteria
  • Patients ≥18 years old at diagnosis
  • Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019
  • At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period
Exclusion Criteria
  • Patients with no medical chart available
  • Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data)
  • Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment
  • Patients with secondary AML
  • Patients with any concomitant primary malignancy
  • Patients with acute promyelocytic leukemia (APL)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants According to Karnofsky Performance ScoresAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score was 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Score:100=normal no complaints; no disease evidence,90=able to carry normal activity; minor signs/symptoms of disease,80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry normal activity, 60=required occasional assistance, able to care for personal needs, 50=required considerable assistance \& frequent medical care, 40=disabled; required special care/assistance,30=severely disabled; hospital admission indicated;20=very sick; hospital admission necessary,10=moribund and 0=dead.

Number of Participants According to Year of DiagnosisAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.

Number of Participants According to Classification for Standard Newly AML TherapyFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants classified as fit or unfit for the standard newly AML therapy according to different lines of treatment (LOT) were reported in this outcome measure.

Number of Participants According to Drug Regimen Prescribed for Newly AMLFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for newly AML were reported by each line of treatment (LOT). Drug regimen included standard 7+3, Histone deacetylases (HDACs), Low-dose Cytarabine (LDAC), FLAG (fludarabine + high-dose cytarabine + G-CSF (Granulocyte colony-stimulating factor), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Hypomethylating agents (HMA), CLAG (Cladribine + Cytarabine + G-CSF), MEC (mitoxantrone, etoposide and intermediate dose cytarabine), MICE and other.

Number of Participants According to Health Insurance TypeAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants according to type of health insurance (public or private) were reported in this outcome measure.

Number of Participants According to Country of ResidenceAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.

Number of Participants With ComorbiditiesAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.

Number of Participants According to Family History of Hematological MalignanciesAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants who had a family history of hematological malignancies were reported in this outcome measure.

Number of Participants With Prior Exposure to Toxic AgentsAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.

Number of Participants With Prior Exposure to a High Dose of RadiationAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.

Number of Participants According to Reason for Exposure to High Dose of RadiationAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.

Number of Participants With Bleeding HistoryAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Number of participants with bleeding history were reported in this outcome measure.

Number of Participants With Tobacco Consumption HabitsAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.

Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status ScoresAt index (anytime between 01-Jan-2015 and 31-Dec-2019; approximately 5 years); data collected and observed retrospectively over 11 months

ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2, 3 and 4) was reported.

Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALLFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

A regimen was defined as a plan for the dose, schedule, and length of treatment. A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL were reported by each LOT is reported. Drug regimen included Hyper- CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter study group for ALL (GMALL), Group for Research on Adult Acute Lymphoblastic Leukemia (GRAAL), Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab, Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF), Other. One participant could be prescribed more than 1 drug regimen.

Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AMLFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.

Number of Participants According to Regimen Type in Newly AMLFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to drug regimen prescribed for newly AML is reported by each LOT. Induction was the first phase of treatment. Consolidation was given after the participant had recovered from induction. Maintenance was given to maintain the remission and further prevent a relapse. Salvage was used when a disease did not respond to all other standard treatments tried.

Treatment DurationFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

The duration of treatment according to different treatment lines were reported.

Time to Next TreatmentFrom start of front-line therapy until start of subsequent line of therapy, last visit/contact/death (up to maximum of 94.6 months);data collected and observed retrospectively over 11 month

Time to next treatment was considered as the time from the start date of the front-line therapy to the start date of a subsequent line of therapy. Participants without a subsequent line of therapy were censored at study enrollment, last visit, last contact, or death, whichever comes first.

Total Number of CyclesFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Total number of cycles according to each line of treatment is reported in this outcome measure.

Number of Participants Who Withdrew RegimenFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.

Number of Participants According to Reasons for Withdrawing RegimenFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to reasons such as progression of the disease, Adverse event toxicity, participants refusal to continue the treatment scheme, cost related or access barriers and other for withdrawing regimen according to each line of treatment were reported in this outcome measure. One participant could have more than one reason for withdrawing regimen.

Number of Participants With Dose ReductionFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.

Number of Participants With Central Nervous System (CNS) Involvement at Disease ProgressionAt disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.

Duration of RadiotherapyFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.

Absolute Value of Hemoglobin After Start of Treatment LineAfter start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Value of White Blood Cell Count Before Treatment LineUp to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months

Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.

Dose of RadiotherapyFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.

Number of Participants According to Location of Application of RadiotherapyFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.

Number of Participants According to Intrathecal ChemotherapyFrom start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to intrathecal chemotherapy such as methotrexate, cytarabine, prednisone, dexamethasone, other according to each line of treatment is reported in this outcome measure. One participant may receive more than one intrathecal chemotherapy.

Number of Participants With Stem Cell Transplant (SCT)From start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants with stem cell transplant were reported in this outcome measure.

Absolute Value of Hemoglobin Before Treatment LineUp to 48 hours before each treatment cycle till the end of treatment, disease progression and/or death from any cause; data collected and observed retrospectively over 11 months

Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Value of White Blood Cell Count After Start of Treatment LineAfter start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Neutrophil Count (ANC) Before Treatment LineUp to 1 week before treatment initiation; data collected and observed retrospectively over 11 months

Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Neutrophil Count (ANC) After Start of Treatment LineAfter start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Value of Blast Count Before Treatment LineUp to 1 week before treatment initiation; data collected and observed retrospectively over 11 months

Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Value of Blast Count After Start of Treatment LineAfter start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Value of Platelets Count Before Treatment LineUp to 1 week before treatment initiation; data collected and observed retrospectively over 11 months

Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.

Absolute Value of Platelets Count After Start of Treatment LineAfter start of treatment until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Absolute value of platelet count after start of treatment according to different treatment lines were reported.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Molecular Test PerformedAt diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants with different molecular test KGB, Fluorescence in situ hybridization (FISH), Reverse transcription polymerase chain reaction (RT-PCR), Next-generation sequencing (NGS), Array Comparative Genomic Hybridization (ACGH), Other performed were reported.

Number of Participants According to AML Translocation Results: AML Arm OnlyFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months

Number of participants according to different AML translocation were reported in this outcome measure.

Number of Participants According to Molecular Profile in Newly AML ArmFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months ); data collected and observed retrospectively over 11 months

Number of participants according to molecular profile were reported in this outcome measure.

Number of Participants According to AML WHO Classification: AML Arm OnlyFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to AML WHO classification were reported in this outcome measure.

Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm OnlyAt diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to ALL WHO classification were reported in this outcome measure.

Number of Participants According to Immunophenotyping Results for AML Arm OnlyFrom diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.

Number of Participants According to Immunophenotyping Results for R/R B-cell ALLAt diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.

Number of Participants According to Molecular Profile in R/R B-cell ALLAt diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to molecular profile in R/R B-cell ALL were reported.

Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm OnlyAt diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

A good prognosis means that there was a high chance of recovery or healing. Intermediate prognosis was a term used to describe the likelihood of recovery or survival from a disease or condition that was neither favorable nor unfavorable. A poor prognosis refers to an estimation that there was a low chance of recovery from a disease.

Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN)" under favorable (indicates a low probability or impact of adverse outcomes), intermediate (associated with moderate changes) and Poor/ Adverse (occurrence of a risk was high and the impact of the risk is severe) were reported.

Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALLFrom the diagnosis for de novo ALL diagnosis date to study enrolment date (anytime between 2001-2014 approximately 13 years); data collected and observed retrospectively over 11 months

A regimen could be a treatment that consisted of one or combined (two or more) drugs. Number of participants according to drug regimen prescribed for R/R B-cell ALL is reported. Hyper- CVAD (hyper fractionated cyclophosphamide, vincristine, doxorubicin, and prednisolone), German multicenter ALL (GMALL), GRAAL, Berlin-Frankfurt-Münster (BFM), Inotuzumab, Blinatumomab Chimeric antigen receptor T-cell therapies (CAR-T), Tyrosine kinase inhibitors (TKI), FLAG (fludarabine + high-dose cytarabine + G-CSF), FLAG-IDA Regimen (Fludarabine, Cytarabine, Idarubicin and G-CSF). The initial diagnosis of acute leukemia could have been before 01-Jan-2015.

Time From Start of First-Line Treatment to Start of the Adverse EventFrom start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Time from start of first line treatment to start of the adverse event were reported. An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Number of Clinical EventsFrom diagnosis until end of treatment, disease progression, death or loss of follow-up (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of clinical events were reported in this outcome measure.

Event Free Survival (EFS)From start of treatment until failure to achieve CR, PD or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

EFS =time since treatment initiation until failure to achieve complete remission (CR) or disease progression (PD) after CR, or death from any cause. Participants not known to have any of these events were censored on the date they were last examined, study enrollment, last contact, whichever came later.CR=participants response to treatment according to the medical chart. AML CR =no physical signs of leukemia, bone marrow with active hematopoiesis, \<5% bone marrow blasts and more than 1\* 10\^9 cells/l granulocytes and more than 100\* 10\^9 cells/l platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia), PD=according to medical chart and accompanied by a decline in absolute neutrophil count (ANC) and platelets and increased transfusion requirement and decline in performance status or increase in symptoms.

Number of ProceduresFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Different clinical procedures were reported. One participant could have more than one procedure.

Overall Survival (OS)From start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

OS was defined as the time from the date of diagnosis or treatment until date of death due to any cause. If there was no death, the participants were censored at last visit or contact, whichever came later.

Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months

Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.

Relapse Free Survival-Newly Diagnosed AML Participants OnlyFrom date of remission until relapse or death or censoring date (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Relapse was a deterioration in health status after an improvement. Relapse free survival was considered as date of achievement of a remission until the date of relapse or death from any cause; participants not known to have relapsed or died at last follow-up were censored on the date they were last examined. CR=a participant's response to treatment according to the medical chart. Usually, AML complete remission defined as no physical signs of leukemia, bone marrow with active hematopoiesis, \<5% bone marrow blasts and more than 1\* 10\^9 cells/L granulocytes and more than 100\* 10\^9 cells/L platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia.

Number of HospitalizationsFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.

Number of Participants According to Treatment ResponseFrom start of treatment until disease progression, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Complete remission-response (CR) defined as no physical signs of leukemia, bone marrow with active hematopoiesis, \<5% bone marrow blasts and more than 1×109/l granulocytes and more than 100×109/l platelets in blood and no circulating leukemic blasts or evidence of extramedullary leukemia. Complete response with incomplete blood count recovery (CRi): also known as CR with incomplete hematologic recovery, participant's response to treatment according to medical chart. Partial remission: participant's response to treatment according to medical chart. All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%. Disease progression: \>25% increase in sum of longest diameter of target lesions compared to baseline. Refractory disease: according to medical chart. No CR after 2 courses of intensive induction treatment; excluding participants with death in aplasia or death due to indeterminate cause.

Reason for HospitalizationFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Reason for hospitalizations according to reasons such as ALL-AML treatment, adverse events were reported. One participant could have more than one reason for hospitalization.

Duration in Intensive Care UnitFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Mean duration in intensive care unit were reported in this outcome measure.

Number of Participants According to SurgeryFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number of participants according to type of surgery were reported in this outcome measure.

Number of Blood TransfusionsFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.

Number of Concomitant MedicationsFrom diagnosis until end of treatment, loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.

Trial Locations

Locations (14)

Hospital Beneficência Portuguesa de São Paulo

🇧🇷

São Paulo, Brazil

Hospital Guillermo Grant Benavente

🇨🇱

Concepcion, Chile

Hospital Italiano de La Plata

🇦🇷

La Plata, Buenos Aires, Argentina

Hospital Universitario Austral

🇦🇷

Pilar, Buenos Aires, Argentina

FUNDALEU - Fundacion para combatir la Leucemia

🇦🇷

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Instituto COI de Pesquisa

🇧🇷

Rio de Janeiro, Brazil

Hospital Privado Centro Medico de Cordoba S.A.

🇦🇷

Cordoba, Argentina

Sanatorio Allende

🇦🇷

Cordoba, Argentina

Hospital São Rafael

🇧🇷

Salvador, Bahia, Brazil

Fundação Doutor Amaral Carvalho

🇧🇷

Jaú, SAO Paulo / Brazil, Brazil

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

🇧🇷

São Paulo, Brazil

Hospital Israelita Albert Einstein

🇧🇷

São Paulo, Brazil

Fundacion Santa Fe de Bogota

🇨🇴

Bogotá, Colombia

Oncomedica SA

🇨🇴

Montería, Colombia

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