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

July 19, 2016 updated by: Janssen-Cilag Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

5443

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma De Buenos Aires, Argentina
      • Cordoba, Argentina
      • La Plata Lpl Lpl, Argentina
  • Brazil
      • Belo Horizonte, Brazil
      • Fortaleza, Brazil
      • Goiânia, Brazil
      • Porto Alegre, Brazil
      • Sao Jose Do Rio Preto, Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil
  • Chile
      • Santiago, Chile
  • Colombia
      • Bogota, Colombia
      • Bogota N/A, Colombia
      • Bogotá Dc, Colombia
      • Cali, Colombia
      • Floridablanca, Colombia
      • Medellín, Colombia
  • Guatemala
      • Guatemala City, Guatemala
  • Mexico
      • Ciudad De Mexico, Mexico
      • Huixquilucan, Mexico
      • Mexico, Mexico
      • Mexico City, Mexico
      • Mexico Df, Mexico
      • Monterrey, Mexico
      • Toluca, Mexico
  • Panama
      • Panama, Panama
      • Panama Republic Panama, Panama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Chronic Lymphocytic Leukemia (CLL)
This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.
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.
Other: Multiple Myeloma (MM)
This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.
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.
Other: Non-Hodgkin's lymphoma (NHL)
This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR105066
  • PCI-32765MMY4001 (Other Identifier: Janssen-Cilag Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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