Latin American Real-world Study in Acute Leukemia (LOYAL)

Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Acute Lymphoid Leukemia

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.

• Study Type: Observational
• Enrollment (Actual): 589

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5000JHQ
    • Sanatorio Allende
  • Cordoba, Argentina, 5016
    • Hospital Privado Centro Medico de Cordoba S.A.
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, B1900AXI
      • Hospital Italiano de La Plata
    • Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
  • Ciudad Autonoma Buenos Aires
    • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1114
      • Fundaleu - Fundacion Para Combatir La Leucemia
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Instituto COI de Pesquisa
  • São Paulo, Brazil, 05652000
    • Hospital Israelita Albert Einstein
  • São Paulo, Brazil, 01246-000
    • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • São Paulo, Brazil, 01323-001
    • Hospital Beneficência Portuguesa de São Paulo
  • Bahia
    • Salvador, Bahia, Brazil, 41253-190
      • Hospital Sao Rafael
  • SAO Paulo / Brazil
    • Jaú, SAO Paulo / Brazil, Brazil, 17210-120
      • Fundação Doutor Amaral Carvalho
• Chile
  • Concepcion, Chile, 4070038
    • Hospital Guillermo Grant Benavente
• Colombia
  • Bogotá, Colombia, 111071
    • Fundacion Santa Fe de Bogota
  • Montería, Colombia, 230002
    • Oncomedica SA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 years old at diagnosis, with de novo AML or R/R B-cell ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML or R/R ALL within the study period.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Acute Myeloid Leukemia; Patients ≥18 years old at diagnosis, with de novo AML diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML within the study period.
Relapsed/Refractory Acute Lymphoid Leukemia; Patients ≥18 years old at diagnosis, with R/R ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for R/R ALL within the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants According to Health Insurance Type	Number of participants according to type of health insurance (public or private) were reported in this outcome measure.	At 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	Number of participants according to country of residence such as Argentina, Brazil, Chile, and Colombia were reported in this outcome measure.	At 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 Comorbidities	Number of participants with any comorbidity at de novo AML or B-cell ALL diagnosis were reported in this outcome measure.	At 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 Family History of Hematological Malignancies	Number of participants who had a family history of hematological malignancies were reported in this outcome measure.	At 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 Toxic Agents	Number of participants who had any prior exposure to toxic agents were reported in this outcome measure.	At 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	Number of participants with prior exposure to a high dose of radiation were reported in this outcome measure.	At 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	Number of participants according to reason for exposure to high dose of radiation were reported in this outcome measure.	At 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	Number of participants with bleeding history were reported in this outcome measure.	At 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 Tobacco Consumption Habits	Participants with tobacco consumption habits (i.e., Non-smoker, Ex-smoker and others) were reported in this outcome measure.	At 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 Eastern Cooperative Oncology Group (ECOG) Performance Status Scores	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.	At 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 Karnofsky Performance Scores	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.	At 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 Year of Diagnosis	Number of participants according to the year of diagnosis for newly AML or R/R B-cell ALL were reported in this outcome measure.	At 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 Classification for Standard Newly AML Therapy	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.	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 Drug Regimen Prescribed for Newly AML	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.	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 Drug Regimen Prescribed for R/R B-cell ALL	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.	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 Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML	Number of participants prescribed Gemtuzumab, Midostaurin or Venetoclax treatment in newly AML according to different LOT were reported in this outcome measure.	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 Regimen Type in Newly AML	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.	From diagnosis until loss of follow-up or death (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Treatment Duration	The duration of treatment according to different treatment lines were reported.	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
Time to Next Treatment	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.	From 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
Total Number of Cycles	Total number of cycles according to each line of treatment is reported in this outcome measure.	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 Who Withdrew Regimen	Number of participants who withdrew regimen according to each line of treatment is reported in this outcome measure.	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 According to Reasons for Withdrawing Regimen	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.	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 Dose Reduction	Number of participants with dose reduction according to each line of treatment were reported in this outcome measure.	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 Central Nervous System (CNS) Involvement at Disease Progression	Number of participants with CNS involvement at disease progression according to each line of treatment were reported in this outcome measure.	At disease progression (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Duration of Radiotherapy	Mean duration of radiotherapy according to each line of treatment is reported in this outcome measure.	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
Dose of Radiotherapy	Mean dose of radiotherapy according to each line of treatment is reported in this outcome measure.	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 According to Location of Application of Radiotherapy	Number of participants according to location of application of radiotherapy according to each line of treatment is reported in this outcome measure.	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 According to Intrathecal Chemotherapy	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.	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 (SCT)	Number of participants with stem cell transplant were reported in this outcome measure.	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
Absolute Value of Hemoglobin Before Treatment Line	Absolute value of hemoglobin before start of treatment according to each line of treatment was reported in this outcome measure.	Up 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 After Start of Treatment Line	Absolute value of hemoglobin after start of treatment according to each line of treatment was reported in this outcome measure.	After 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 Before Treatment Line	Absolute value of white blood cell count before start of treatment according to each line of treatment was reported in this outcome measure.	Up 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 After Start of Treatment Line	Absolute value of white blood cell count after start of treatment according to each line of treatment was reported in this outcome measure.	After 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 Neutrophil Count (ANC) Before Treatment Line	Absolute value of neutrophil count before start of treatment according to each line of treatment was reported in this outcome measure.	Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute Neutrophil Count (ANC) After Start of Treatment Line	Absolute value of neutrophil count after start of treatment according to each line of treatment was reported in this outcome measure.	After 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 Before Treatment Line	Absolute value of blast count before start of treatment according to each line of treatment was reported in this outcome measure.	Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute Value of Blast Count After Start of Treatment Line	Absolute value of blast count after start of treatment according to each line of treatment was reported in this outcome measure.	After 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 Platelets Count Before Treatment Line	Absolute value of platelet count before start of treatment according to each line of treatment was reported in this outcome measure.	Up to 1 week before treatment initiation; data collected and observed retrospectively over 11 months
Absolute Value of Platelets Count After Start of Treatment Line	Absolute value of platelet count after start of treatment according to different treatment lines were reported.	After 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Molecular Test Performed	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.	At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to AML Translocation Results: AML Arm Only	Number of participants according to different AML translocation were reported in this outcome measure.	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 Molecular Profile in Newly AML Arm	Number of participants according to molecular profile were reported in this outcome measure.	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 WHO Classification: AML Arm Only	Number of participants according to AML WHO classification were reported in this outcome measure.	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 ALL WHO Classification: R/R B-cell ALL Arm Only	Number of participants according to ALL WHO classification were reported in this outcome measure.	At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to Immunophenotyping Results for AML Arm Only	Number of participants according to immunophenotyping assessment results were reported for AML arm in this outcome measure.	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 Immunophenotyping Results for R/R B-cell ALL	Number of participants according to immunophenotyping assessment results were reported for R/R B-cell ALL arm in this outcome measure.	At 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	Number of participants according to molecular profile in R/R B-cell ALL were reported.	At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only	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.	At diagnosis (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)	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.	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 Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL	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.	From 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
Time From Start of First-Line Treatment to Start of the Adverse Event	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.	From start of 1st line treatment until Adverse Event (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months
Number of Clinical Events	Number of clinical events were reported in this outcome measure.	From 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
Event Free Survival (EFS)	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.	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
Overall Survival (OS)	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.	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
Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation	Percentage of participants alive at 1,3 and 5 years since treatment initiation were reported in this outcome measure.	1, 3 and 5 years since treatment initiation; data collected and observed retrospectively over 11 months
Relapse Free Survival-Newly Diagnosed AML Participants Only	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.	From 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
Number of Participants According to Treatment Response	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.	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
Number of Hospitalizations	Number of hospitalizations were reported in this outcome measure. One participant could have more than one hospitalization.	From 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 Hospitalization	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.	From 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
Duration in Intensive Care Unit	Mean duration in intensive care unit were reported in this outcome measure.	From 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 Procedures	Different clinical procedures were reported. One participant could have more than one procedure.	From 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 Surgery	Number of participants according to type of surgery were reported in this outcome measure.	From 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 Blood Transfusions	Number and type of blood transfusions were reported in this outcome measure. One participant could have more than one blood transfusions.	From 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 Concomitant Medications	Concomitant medication: drug treatment for comorbidities, supportive and prophylaxis therapies, or to treat adverse events.	From 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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Relapsed Refractory B-cell Acute Lymphoblastic Leukemia; Acute Leukemia in Latin America; LOYAL study
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: X9001302; LOYAL (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No