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Completed

NCT Number: NCT02559583

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoid Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic Lymphocytic Leukemia (CLL)

Other

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

Multiple Myeloma (MM)

Other

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

Non-Hodgkin's lymphoma (NHL)

Other

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

Primary outcomes

  1. Number of Participants with Previous Comorbidities

    Time frame: 1 year

    Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.

  2. Number of Participants as per treatment therapy received

    Time frame: 1 year

    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.

  3. Overall survival

    Time frame: 1 year

    Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.

  4. Number of Participants with Response to Treatment

    Time frame: 1 year

    Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.

Secondary outcomes

  1. Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)

    Time frame: 1 year

    Incidence of CLL, MM and NHL will be reported. It is a percentage of the population at risk of developing the disease.

  2. Prevalence Percentage of Participants with CLL, MM and NHL

    Time frame: 1 year

    Prevalence 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.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

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

Acronym: HOLA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 24, 2015
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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