N/A
N=589
Latin American Real-world Study in Acute Leukemia
Acute Myeloid Leukemia · Acute Lymphoid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT05166135 ↗Enrolled (actual)
589
Serious AEs
0.3%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants According to Health Insurance Type — 265; 44; 253; 27 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to Health Insurance Type |
265; 44; 253; 27 | — |
| PRIMARY Number of Participants According to Country of Residence |
166; 23; 205; 27; 63; 0 | — |
| PRIMARY Number of Participants With Comorbidities |
273; 23 | — |
| PRIMARY Number of Participants According to Family History of Hematological Malignancies |
21; 3 | — |
| PRIMARY Number of Participants With Prior Exposure to Toxic Agents |
11; 3 | — |
| PRIMARY Number of Participants With Prior Exposure to a High Dose of Radiation |
2; 1 | — |
| PRIMARY Number of Participants According to Reason for Exposure to High Dose of Radiation |
2; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Bleeding History |
30; 6 | — |
| PRIMARY Number of Participants With Tobacco Consumption Habits |
343; 55; 85; 10; 51; 5 | — |
| PRIMARY Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Scores |
136; 29; 185; 21; 45; 7 | — |
| PRIMARY Number of Participants According to Karnofsky Performance Scores |
110; 27; 107; 12; 69; 7 | — |
| PRIMARY Number of Participants According to Year of Diagnosis |
88; 13; 102; 15; 103; 4 | — |
| PRIMARY Number of Participants According to Classification for Standard Newly AML Therapy |
390; 99; 217; 43; 102; 32 | — |
| PRIMARY Number of Participants According to Drug Regimen Prescribed for Newly AML |
390; 3; 25; 3; 3; 47 | — |
| PRIMARY Number of Participants According to Drug Regimen Prescribed for R/R B-cell ALL |
16; 0; 11; 15; 0; 0 | — |
| PRIMARY Number of Participants Prescribed Gemtuzumab, Midostaurin or Venetoclax Treatment in Newly AML |
0; 10; 1; 1; 9; 3 | — |
| PRIMARY Number of Participants According to Regimen Type in Newly AML |
458; 92; 7; 2; 55; 46 | — |
| PRIMARY Treatment Duration |
2.1; 6.4; 2.2; 3.9; 2.3; 1.7 | — |
| PRIMARY Time to Next Treatment |
1.6; 8.4; 2.9; 2.6; 2.0; 2.4 | — |
| PRIMARY Total Number of Cycles |
2.2; 3.1; 2.2; 2.7; 2.2; 2.6 | — |
| PRIMARY Number of Participants Who Withdrew Regimen |
86; 8; 35; 12; 19; 10 | — |
| PRIMARY Number of Participants According to Reasons for Withdrawing Regimen |
14; 3; 28; 2; 0; 0 | — |
| PRIMARY Number of Participants With Dose Reduction |
84; 9; 37; 7; 15; 2 | — |
| PRIMARY Number of Participants With Central Nervous System (CNS) Involvement at Disease Progression |
1; 0; 1; 1; 2; 2 | — |
| PRIMARY Duration of Radiotherapy |
0.3; 0.7; 0.5 | — |
| PRIMARY Dose of Radiotherapy |
300; 2267; 25; 2400; 24 | — |
| PRIMARY Number of Participants According to Location of Application of Radiotherapy |
0; 2; 0; 0; 1; 1 | — |
| PRIMARY Number of Participants According to Intrathecal Chemotherapy |
75; 49; 42; 46; 74; 44 | — |
| PRIMARY Number of Participants With Stem Cell Transplant (SCT) |
125; 26 | — |
| PRIMARY Absolute Value of Hemoglobin Before Treatment Line |
8.3; 9.2; 9.2; 10.4; 9.3; 9.9 | — |
| PRIMARY Absolute Value of Hemoglobin After Start of Treatment Line |
8.3; 10.0; 8.7; 9.3; 8.9; 9.5 | — |
| PRIMARY Absolute Value of White Blood Cell Count Before Treatment Line |
41.7; 35.7; 12.6; 26.8; 17.4; 26.4 | — |
| PRIMARY Absolute Value of White Blood Cell Count After Start of Treatment Line |
7.8; 6.4; 6.7; 10.7; 16.3; 7.9 | — |
| PRIMARY Absolute Neutrophil Count (ANC) Before Treatment Line |
5.0; 4.5; 6.3; 5.7; 8.8; 2.1 | — |
| PRIMARY Absolute Neutrophil Count (ANC) After Start of Treatment Line |
4.1; 6.8; 4.9; 4.4; 7.4; 1.9 | — |
| PRIMARY Absolute Value of Blast Count Before Treatment Line |
37.5; 36.4; 12.0; 16.9; 22.4; 20.4 | — |
| PRIMARY Absolute Value of Blast Count After Start of Treatment Line |
7.7; 7.2; 6.9; 11.9; 7.6; 13.6 | — |
| PRIMARY Absolute Value of Platelets Count Before Treatment Line |
68613; 69220; 153362; 115181; 112035; 91565 | — |
| PRIMARY Absolute Value of Platelets Count After Start of Treatment Line |
105713; 128894; 99613; 78298; 75496; 88996 | — |
| SECONDARY Number of Participants With Molecular Test Performed |
381; 52; 112; 31; 247; 40 | — |
| SECONDARY Number of Participants According to AML Translocation Results: AML Arm Only |
22; 26; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants According to Molecular Profile in Newly AML Arm |
1; 2; 13; 1; 9; 1 | — |
| SECONDARY Number of Participants According to AML WHO Classification: AML Arm Only |
28; 19; 28; 0; 2; 1 | — |
| SECONDARY Number of Participants According to ALL WHO Classification: R/R B-cell ALL Arm Only |
30; 0; 17; 3; 0; 1 | — |
| SECONDARY Number of Participants According to Immunophenotyping Results for AML Arm Only |
7; 5; 9; 239; 316; 9 | — |
| SECONDARY Number of Participants According to Immunophenotyping Results for R/R B-cell ALL |
18; 6; 11; 9; 6; 7 | — |
| SECONDARY Number of Participants According to Molecular Profile in R/R B-cell ALL |
1; 0; 21; 0; 3; 28 | — |
| SECONDARY Number of Participants According to ALL Cytogenetic Risk Classification: R/R B-cell ALL Arm Only |
1; 16; 29; 6 | — |
| SECONDARY Number of Participants According to AML Cytogenetic Risk Classification Based on 2017 European Leukemia Net (ELN) |
85; 179; 109 | — |
| SECONDARY Number of Participants According to Drug Regimen Prescribed Since Diagnosis of de Novo ALL in R/R B-cell ALL |
13; 0; 7; 16; 0; 1 | — |
| SECONDARY Time From Start of First-Line Treatment to Start of the Adverse Event |
56.0; 39.5 | — |
| SECONDARY Number of Clinical Events |
317; 86; 5; 7; 86; 17 | — |
| SECONDARY Event Free Survival (EFS) |
1.5; 1.8 | — |
| SECONDARY Overall Survival (OS) |
10.6; 19.2 | — |
| SECONDARY Secondary: Percentage of Participants Alive at 1,3 and 5 Years Since Treatment Initiation |
47.7; 67.6; 28.0; 35.2; 24.5; 19.7 | — |
| SECONDARY Relapse Free Survival-Newly Diagnosed AML Participants Only |
3.9 | — |
| SECONDARY Number of Participants According to Treatment Response |
190; 24; 16; 7; 27; 5 | — |
| SECONDARY Number of Hospitalizations |
880; 128 | — |
| SECONDARY Reason for Hospitalization |
1064; 236; 20; 4; 559; 134 | — |
| SECONDARY Duration in Intensive Care Unit |
9.1; 11.4 | — |
| SECONDARY Number of Procedures |
60; 8; 1187; 172; 1494; 311 | — |
| SECONDARY Number of Participants According to Surgery |
9; 0; 2; 2; 4; 0 | — |
| SECONDARY Number of Blood Transfusions |
1032; 121; 107; 16; 1051; 139 | — |
| SECONDARY Number of Concomitant Medications |
268; 36; 252; 34; 219; 36 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05166135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.