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Chronic Lymphocytic Leukemia (CLL)NCT02553304

Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients

An observational study of Chronic Lymphocytic Leukemia (CLL), run by National Health Research Institutes, Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but slowly progressive nature history. However, the clinical course of CLL actually varies widely. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
How many people
256 participants
Where
No sites listed yet
Study dates
Sep 2015to 31 Mar 2021
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chronic lymphocytic leukemia (CLL)Patient

Who may be able to join

  • Patients with confirmed diagnosis of CLL, either histologically proven or with immunophenotypical pattern by flowcytometry
  • The diagnosis of CLL was made after 2000; the complete medical history and the laboratory data are available for collections.
  • Age of 20 or older
  • Willing to cooperate with the informed consent procedure and the collections of blood samples and medical history.
  • There are no limitations about organ functions, performance status, pregnancy or breast feeding status, or concomitant diseases or medicines.
  • The patient's peripheral hemogram shows apparent leukocytosis (>15 k/μL) with lymphocytosis (lymphocytes+atypical lymphocytes >55%); the data should me within 3 months before study enrollment.

Who cannot join

  • The patient's past history, including the diagnostic test results, the prior CLL-related treatment courses, the drug history, et.al, is not available.
  • The patient cannot complete the informed consent procedures.
  • The diagnosis is T-CLL, or the patients have been in complete remission without peripheral leukemia cells.

About this study

Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but slowly progressive nature history. However, the clinical course of CLL actually varies widely. Thus, many clinical and molecular features have been identified for outcome predictions. The accurate predictions of prognosis through those factors help for the decision making on the treatment, i.e. to treat patients of high risk of early progression or poor overall survival (OS) with alternative or investigational therapies, while to avoid unnecessary over-treatment for low-risk patients.

CLL is much less prevalent in Eastern countries; presently, most available data on CLL are derived mainly from Western countries. However, a previous report concerning the epidemiology of CLL in Taiwan revealed a drastic increase in the age-adjusted incidence of CLL, a trend not found in Western countries where the incidence rate of CLL remained steadily stable over time. In addition to this epidemiological difference, a population-based analysis has found the overall outcome of CLL, estimated by relative survivals, is steadily much poorer in Taiwanese patients than in US Caucasians. In another report about the cytogenetic profiles in a small cohort of CLL patients in Taiwan, a novel cytogenetic abnormality was found to correlate with poorer outcomes. These reports suggest the existence of ethnic differences in the disease natures of CLL between the East and the West.

To delineate the possible underlying racial differences, especially in the molecular prognostic profiles that might underlie the outcome disparity between Taiwanese and western CLL patients, a comprehensive surveillance of the molecular profiles for CLL in Taiwan is of importance. In this study, we are going to enroll around 250 CLL patients; their clinical parameters will be recorded, their blood samples will be collected for a panel of molecular and cytogenetic factor studies. The molecular markers to be tested in this project include (but not limited to) cytogenetic abnormalities by fluorescent-in-situ hybridization (FISH), immunoglobulin heavy chain variable region (IGHV) hypermutation status, gene mutations for Notch1, SF3B1, p53, MyD88, and BIRC3, and the expressions for ZAP70 and stem cell factor (SCF). These proposed markers include not only the conventional prognostic markers derived from Western studies, and also some novel explorations from our preliminary results, such as SCF and trisomy 3. Through this study, a comprehensive profile of CLL in Taiwan will be established to identify the characteristics of CLL in Taiwanese patients and to address the underlying factors of ethnic differences in the disease nature and outcomes of this disease.

Read the detailed description

Chronic lymphocytic leukemia (CLL) is the most common leukemia in adults in Western countries; it is stratified as a subtype of indolent lymphoid malignancy with a long but slowly progressive nature history. However, the clinical course of CLL actually varies widely. Thus, many clinical and molecular features have been identified for outcome predictions. The accurate predictions of prognosis through those factors help for the decision making on the treatment, i.e. to treat patients of high risk of early progression or poor overall survival (OS) with alternative or investigational therapies, while to avoid unnecessary over-treatment for low-risk patients.

CLL is much less prevalent in Eastern countries; presently, most available data on CLL are derived mainly from Western countries. However, a previous report concerning the epidemiology of CLL in Taiwan revealed a drastic increase in the age-adjusted incidence of CLL, a trend not found in Western countries where the incidence rate of CLL remained steadily stable over time. In addition to this epidemiological difference, a population-based analysis has found the overall outcome of CLL, estimated by relative survivals, is steadily much poorer in Taiwanese patients than in US Caucasians. In another report about the cytogenetic profiles in a small cohort of CLL patients in Taiwan, a novel cytogenetic abnormality was found to correlate with poorer outcomes. These reports suggest the existence of ethnic differences in the disease natures of CLL between the East and the West.

To delineate the possible underlying racial differences, especially in the molecular prognostic profiles that might underlie the outcome disparity between Taiwanese and western CLL patients, a comprehensive surveillance of the molecular profiles for CLL in Taiwan is of importance. In this study, we are going to enroll around 250 CLL patients; their clinical parameters will be recorded, their blood samples will be collected for a panel of molecular and cytogenetic factor studies. The molecular markers to be tested in this project include (but not limited to) cytogenetic abnormalities by fluorescent-in-situ hybridization (FISH), immunoglobulin heavy chain variable region (IGHV) hypermutation status, gene mutations for Notch1, SF3B1, p53, MyD88, and BIRC3, and the expressions for ZAP70 and stem cell factor (SCF). These proposed markers include not only the conventional prognostic markers derived from Western studies, and also some novel explorations from our preliminary results, such as SCF and trisomy 3. Through this study, a comprehensive profile of CLL in Taiwan will be established to identify the characteristics of CLL in Taiwanese patients and to address the underlying factors of ethnic differences in the disease nature and outcomes of this disease.

Study milestone dates: Study Start (First Patient First Visit Date): July 2015,Recruitment end (Last Patient First Visit): July 2018.,Study end (Last Patient Last Visit): July 2020

Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. molecular prognostic profiles

    establish the biological profiles of CLL

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
256 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02553304
Sponsor's protocol ID
T1914
Status last verified
Apr 2022
First submitted
15 Sep 2015
Last updated
7 Apr 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia (CLL), run by National Health Research Institutes, Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

molecular prognostic profiles (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.

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