Observational Study in Participants With Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) in Latin America
HOLA
Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma
2 other identifiers
observational
5,443
7 countries
23
Brief Summary
The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 20, 2016
July 1, 2016
1.9 years
April 23, 2015
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Previous Comorbidities
Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.
1 year
Number of Participants as per treatment therapy received
Cancer treatment (Chronic Lymphocytic Leukemia \[CLL\], Multiple Myeloma \[MM\] and non-Hodgkin lymphoma \[NHL\]) for all participants is summarized by the number of participants who had any type of surgery or radiotherapy (external radiation or brachytherapy) or other drug treatments.
1 year
Overall survival
Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.
1 year
Number of Participants with Response to Treatment
Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.
1 year
Secondary Outcomes (2)
Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)
1 year
Prevalence Percentage of Participants with CLL, MM and NHL
1 year
Study Arms (3)
Participants with Chronic Lymphocytic Leukemia (CLL)
This is an observational study. Data will be captured for Participant's with diagnosis of Chronic Lymphocytic Leukemia according to hospital records in the questionnaire provided by the Sponsor.
Participants with Multiple Myeloma (MM)
This is an observational study. Data will be captured for Participant's with diagnosis of Multiple Myeloma (MM) according to hospital records in the questionnaire provided by the Sponsor.
Participants with Non-Hodgkin's lymphoma (NHL)
This is an observational study. Data will be captured for Participant's with diagnosis of non-Hodgkin's lymphoma (NHL) data according to hospital records in the questionnaire provided by the Sponsor.
Interventions
This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.
This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.
This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.
Eligibility Criteria
Participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America
You may qualify if:
- Diagnosis of chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL) anytime since January 1, 2006
- At least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis
- Participant must sign a participation agreement/informed consent form (ICF)
You may not qualify if:
- \- Having one and only one consult in the center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Córdoba, Argentina
Unknown Facility
La Plata Lpl Lpl, Argentina
Unknown Facility
Belo Horizonte, Brazil
Unknown Facility
Fortaleza, Brazil
Unknown Facility
Goiânia, Brazil
Unknown Facility
Porto Alegre, Brazil
Unknown Facility
São José do Rio Preto, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Santiago, Chile
Unknown Facility
Bogotá, Colombia
Unknown Facility
Bogotá Dc, Colombia
Unknown Facility
Cali, Colombia
Unknown Facility
Floridablanca, Colombia
Unknown Facility
Medellín, Colombia
Unknown Facility
Guatemala City, Guatemala
Unknown Facility
Huixquilucan, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
México, Mexico
Unknown Facility
Monterrey, Mexico
Unknown Facility
Toluca, Mexico
Unknown Facility
Panama City, Panama
Unknown Facility
Panama Republic Panama, Panama
Related Publications (1)
Chiattone C, Gomez-Almaguer D, Pavlovsky C, Tuna-Aguilar EJ, Basquiera AL, Palmer L, de Farias DLC, da Silva Araujo SS, Galvez-Cardenas KM, Gomez Diaz A, Lin JH, Chen YW, Machnicki G, Mahler M, Parisi L, Barreyro P. Real-world analysis of treatment patterns and clinical outcomes in patients with newly diagnosed chronic lymphocytic leukemia from seven Latin American countries. Hematology. 2020 Dec;25(1):366-371. doi: 10.1080/16078454.2020.1833504.
PMID: 33095117DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Ltd. Clinical Trial
Janssen-Cilag Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
September 24, 2015
Study Start
July 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 20, 2016
Record last verified: 2016-07