Chronic Lymphocytic LeukemiaNCT01739491
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Janssen Pharmaceutica.
Trial summary
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult Filipino patients who are diagnosed with chronic lymphocytic leukemia.
Who may be able to join
- Adult Filipino patients with chronic lymphocytic leukemia
- Patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic Binet stage B or C) and for whom fludarabine combination chemotherapy is not appropriate
- World health organization performance Status of 0, 1, or 2
- Need-to-treat criteria in B-cell chronic lymphocytic leukemia
Who cannot join
- Had received previous treatment with other cytotoxic drugs
- Had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)
- Concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection
- Patients with severe renal and hepatic impairment
- Patients with severe bone marrow suppression and severe blood count alterations
- Pregnant women and lactating mothers
About this study
Official title: A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).
Read the detailed description
This is a Phase IV, open label (all people know the identity of the intervention), multi-center, observational (a scientific study to make a clear and easy understanding of the cause and effect relationship) study of bendamustine. The study duration is of 24 Weeks to coincide with the 4 weeks-6 cycles bendamustine treatment. The study will run for three years, and will enroll 10 percent of patient who would use this product, as a requirement of the Philippine Food and Drug Administration (FDA). Approximately fifty patients will be enrolled in this study. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- No intervention
- Keywords
- Chronic lymphocytic leukemia, Bendamustine hydrochloride, Leukemia, Filipino
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
This is an obeservational study. Bendamustine hydrochloride will be administered (as per product insert) through intravenous infusion over 30-60 minutes at 100 mg/meter square body surface area on days 1 and 2 of a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine hydrochloride | Adult Filipino patients with chronic lymphocytic leukemia will be taking bendamustine hydrochloride as per the dosing regimen given on product insert approved in Philippines. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incidence of adverse events
Measured: Up to Week 24
Number of patients with incidence of discontinuation of study medication due to adverse events
Measured: Up to Week 24
Secondary outcomes (5)
Number of patients who show complete remission
Number of patients with complete remission will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.
Measured: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients who show partial remission
Number of patients with partial remission will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.
Measured: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients with stable disease
Number of patients with stable disease will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.
Measured: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients who show disease progression
Number of patients with disease progression will be evaluated using the National Cancer Institute-Sponsored Working Group (NCISWG) criteria.
Measured: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients with lack of effect (failure of expected pharmacologic action)
Measured: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startOct 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Why it stopped: The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jannsen Pharmaceutica Clinical trial, Study director, Jannsen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739491
- Sponsor's protocol ID
- CR100917
- Other IDs
- BENDAMUSCLL4001
- Status last verified
- Nov 2015
- First submitted
- 29 Nov 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Surveillance Study on the Safety And Effectiveness of Bendamustine Hydrochloride Among Adult Filipino Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01739491
- Acronym / sponsor ID
- CR100917
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic lymphocytic leukemia, Bendamustine hydrochloride, Leukemia, Filipino
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 3 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).
Detailed description
This is a Phase IV, open label (all people know the identity of the intervention), multi-center, observational (a scientific study to make a clear and easy understanding of the cause and effect relationship) study of bendamustine. The study duration is of 24 Weeks to coincide with the 4 weeks-6 cycles bendamustine treatment. The study will run for three years, and will enroll 10 percent of patient who would use this product, as a requirement of the Philippine Food and Drug Administration (FDA). Approximately fifty patients will be enrolled in this study. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine hydrochloride | – | Drug: No interventionAdult Filipino patients with chronic lymphocytic leukemia will be taking bendamustine hydrochloride as per the dosing regimen given on product insert approved in Philippines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult Filipino patients who are diagnosed with chronic lymphocytic leukemia.
Key inclusion criteria (4 listed)
- Adult Filipino patients with chronic lymphocytic leukemia
- Patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic Binet stage B or C) and for whom fludarabine combination chemotherapy is not appropriate
- World health organization performance Status of 0, 1, or 2
- Need-to-treat criteria in B-cell chronic lymphocytic leukemia
Key exclusion criteria (6 listed)
- Had received previous treatment with other cytotoxic drugs
- Had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)
- Concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection
- Patients with severe renal and hepatic impairment
- Patients with severe bone marrow suppression and severe blood count alterations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an obeservational study. Bendamustine hydrochloride will be administered (as per product insert) through intravenous infusion over 30-60 minutes at 100 mg/meter square body surface area on days 1 and 2 of a 28-day cycle. | Drug | Bendamustine hydrochloride |
Primary outcome
Number of patients with incidence of adverse events
Time frame: Up to Week 24
Number of patients with incidence of discontinuation of study medication due to adverse events
Time frame: Up to Week 24
5 secondary outcomes
Number of patients who show complete remission
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients who show partial remission
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients with stable disease
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients who show disease progression
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Number of patients with lack of effect (failure of expected pharmacologic action)
Time frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannsen Pharmaceutica Clinical trial study director
Jannsen Pharmaceutica
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Janssen Pharmaceutica.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 2 Dec 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with incidence of adverse events (time frame: Up to Week 24). The study lists 2 primary outcomes in all. 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 2 Dec 2015.