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Observational Study in Participants With Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) in Latin America

Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02559583
Acronym
HOLA
Enrollment
5443
Registered
2015-09-24
Start date
2014-07-31
Completion date
2016-06-30
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoid, Lymphoma, Multiple Myeloma, Non-Hodgkin

Keywords

Multiple Myeloma, chronic lymphocytic leukemia, Non-Hodgkin lymphoma

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.

Detailed description

This is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of CLL, MM or NHL anytime since 01 January 2006. Only data available from clinical practice will be collected. All eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. The period of observation will span from 01 January 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. Participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.

Interventions

OTHERChronic Lymphocytic Leukemia (CLL)

This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.

OTHERMultiple Myeloma (MM)

This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.

OTHERNon-Hodgkin's lymphoma (NHL)

This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.

Sponsors

Janssen-Cilag Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

\- Having one and only one consult in the center

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Previous Comorbidities1 yearComorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.
Number of Participants as per treatment therapy received1 yearCancer 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.
Overall survival1 yearOverall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.
Number of Participants with Response to Treatment1 yearNumber of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.

Secondary

MeasureTime frameDescription
Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)1 yearIncidence of CLL, MM and NHL will be reported. It is a percentage of the population at risk of developing the disease.
Prevalence Percentage of Participants with CLL, MM and NHL1 yearPrevalence of CLL, MM and NHL will be reported. Prevalence will be estimated using available population demographic information as the denominators and using the percentage of registered participants with those cancers at the sites as the numerators.

Countries

Argentina, Brazil, Chile, Colombia, Guatemala, Mexico, Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026