Latin American Real-world Study in Acute Leukemia

NCT05166135 | Completed Results

• 2 other identifiers: X9001302LOYAL
• Study Type: observational
• Target: 589
• Locations: 4 countries
• Sites: 14

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoid Leukemia

Keywords

Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Relapsed Refractory B-cell Acute Lymphoblastic Leukemia; Acute Leukemia in Latin America; LOYAL study

Outcome Measures

Primary Outcomes (39)

• 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 Outcomes (25)

• Number of Participants With Molecular Test Performed

  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

  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

  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

  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

  At diagnosis (up to maximum of 94.6 months); data collected and observed retrospectively over 11 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

Hospital Italiano de La Plata

La Plata, Buenos Aires, B1900AXI, Argentina

Location

Hospital Universitario Austral

Pilar, Buenos Aires, B1629ODT, Argentina

Location

FUNDALEU - Fundacion para combatir la Leucemia

Buenos Aires, Ciudad Autonoma Buenos Aires, 1114, Argentina

Location

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, 5016, Argentina

Location

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

Location

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Fundação Doutor Amaral Carvalho

Jaú, SAO Paulo / Brazil, 17210-120, Brazil

Location

Instituto COI de Pesquisa

Rio de Janeiro, 22793-080, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

Hospital Beneficência Portuguesa de São Paulo

São Paulo, 01323-001, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, 05652000, Brazil

Location

Hospital Guillermo Grant Benavente

Concepción, 4070038, Chile

Location

Fundacion Santa Fe de Bogota

Bogotá, 111071, Colombia

Location

Oncomedica SA

Montería, 230002, Colombia

Location

Related Links

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

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 21, 2021
• Study Start: December 10, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2); CL (1); AR (5); BR (6)