Chronic Lymphocytic LeukemiaNCT02381899
Observational Study in CLL Patients Receiving BR
An observational study of Chronic Lymphocytic Leukemia, run by Czech CLL Study Group at 5 sites in Czechia.
Trial summary
The purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Bendamustine and Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 83 participants
- Where
- 5 sitesCzechia
- Study dates
- Sep 2014to Dec 2018
- 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: Patients with chronic lymphocytic leukemia.
Who may be able to join
- Confirmed diagnosis of chronic lymphocytic leukemia
- Patients treated with first-line BR for active disease requiring treatment
- Cumulative Illness Rating Scale (CIRS) > 6
- Informed consent to data collection
Who cannot join
- Patients treated with BR within prospective clinical trials
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites
Department of Hematology - Oncology, University Hospital
Brno, 60500
4th Department of Medicine - Hematology, University Hospital
Hradec Králové, 50005
Department of Hematology, University Hospital
Pilsen, 30599
Department of Medicine - Hematology, University Hospital Kralovske Vinohrady
Prague, 10034
1st Department of Medicine - Hematology, General University Hospital
Prague, 12808
About this study
Official title: Observational Study in Comorbid Patients With Chronic Lymphocytic Leukemia Receiving First-line Bendamustine With Rituximab
The purpose of this observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.
Read the detailed description
BR (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate.
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of BR for CLL patients treated in routine clinical practice.
Specific data of interest are: comorbid conditions, CLL characteristics, adverse events, reasons for discontinuation BR, overall response rates, complete response rate, progression-free survival, overall survival.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Bendamustine and Rituximab
- Keywords
- chronic lymphocytic leukemia, bendamustine, rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine and RituximabDrug
Also called Mabthera, Levact
Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| BR in CLL | Patients receive bendamustine hydrochloride 90mg/m2 IV on days 1 and 2 each cycle. Patients also receive rituximab 375 mg/m2 IV on day 1 at first cycle and 500 mg/m2 on day 1 all subsequent cycles. Receives: Drug: Bendamustine and Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (myelotoxicity, infections, etc.)
Measured: 8 months
Overall response rate
Response to treatment was assessed using National Cancer Institute-sponsored Working Group criteria, including bone marrow examination and radiographic confirmation of complete response.
Measured: 8 months
Secondary outcomes (2)
Progression-free survival
Calculated from the start of therapy until disease progression or death
Measured: 3 years
Overall survival
Time interval from the start of therapy until death form any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech CLL Study Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martin Spacek, MD, PhD, Study chair, Czech CLL Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381899
- Sponsor's protocol ID
- BR-1
- Status last verified
- Jan 2019
- First submitted
- 3 Mar 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fischer K, Cramer P, Busch R, Bottcher S, Bahlo J, Schubert J, Pfluger KH, Schott S, Goede V, Isfort S, von Tresckow J, Fink AM, Buhler A, Winkler D, Kreuzer KA, Staib P, Ritgen M, Kneba M, Dohner H, Eichhorst BF, Hallek M, Stilgenbauer S, Wendtner CM. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012 Sep 10;30(26):3209-16. doi: 10.1200/JCO.2011.39.2688. Epub 2012 Aug 6.
PubMed 22869884Obrtlikova P, Spacek M, Doubek M, Hadrabova M, Panovska A, Svackova K, Trneny M. Bendamustine with rituximab (BR) is safe treatment option with high response rate for chronic lymphocytic leukemia in elderly patients with comorbidities. LEUKEMIA & LYMPHOMA 56(1SI): 151-153, 2015 [abstract #180].
Spacek M, Obrtlikova P, Hadrabova M, Cmunt E, Karban J, Molinsky J, Simkovic M, Mocikova H, Mohammadova L, Panovska A, Novak J, Smolej L, Doubek M, Trneny M. Observational study in comorbid patients with CLL receiving first-line rituximab-bendamustine. XVII International Workshop on CLL, New York, May 12-15, 2017 [abstract #148]
Spacek M, Obrtlikova P, Hrobkova S, Cmunt E, Karban J, Molinsky J, Simkovic M, Mocikova H, Mohammadova L, Panovska A, Novak J, Trneny M, Smolej L, Doubek M. Prospective observational study in comorbid patients with chronic lymphocytic leukemia receiving first-line bendamustine with rituximab. Leuk Res. 2019 Apr;79:17-21. doi: 10.1016/j.leukres.2019.02.002. Epub 2019 Feb 15.
PubMed 30797139
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Comorbid Patients With Chronic Lymphocytic Leukemia Receiving First-line Bendamustine With Rituximab
- ClinicalTrials.gov ID
- NCT02381899
- Acronym / sponsor ID
- BR-1
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- chronic lymphocytic leukemia, bendamustine, rituximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Czech CLL Study GroupResearch network
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Mar 2015 (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 observational study is to provide additional data to confirm the safety profile and efficacy of bendamustine and rituximab (BR) chemotherapy for chronic lymphocytic leukemia patients with significant comorbidities treated in routine clinical practice.
Detailed description
BR (bendamustine, rituximab) combination is currently accepted as a first-line treatment of chronic lymphocytic leukemia (CLL) in patients for whom fludarabine combination chemotherapy is not appropriate.
The objective of this observational study is to provide additional data to confirm the safety profile and efficacy of BR for CLL patients treated in routine clinical practice.
Specific data of interest are: comorbid conditions, CLL characteristics, adverse events, reasons for discontinuation BR, overall response rates, complete response rate, progression-free survival, overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BR in CLL | – | Drug: Bendamustine and RituximabPatients receive bendamustine hydrochloride 90mg/m2 IV on days 1 and 2 each cycle. Patients also receive rituximab 375 mg/m2 IV on day 1 at first cycle and 500 mg/m2 on day 1 all subsequent cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic lymphocytic leukemia.
Key inclusion criteria (4 listed)
- Confirmed diagnosis of chronic lymphocytic leukemia
- Patients treated with first-line BR for active disease requiring treatment
- Cumulative Illness Rating Scale (CIRS) > 6
- Informed consent to data collection
Key exclusion criteria (1 listed)
- Patients treated with BR within prospective clinical trials
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 |
|---|---|---|
| Bendamustine and RituximabAlso: Mabthera, LevactPatients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. | Drug | BR in CLL |
Primary outcome
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria
Time frame: 8 months
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (myelotoxicity, infections, etc.)
Overall response rate
Time frame: 8 months
Response to treatment was assessed using National Cancer Institute-sponsored Working Group criteria, including bone marrow examination and radiographic confirmation of complete response.
2 secondary outcomes
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Background: PubMed 22869884Fischer K, Cramer P, Busch R, Bottcher S, Bahlo J, Schubert J, Pfluger KH, Schott S, Goede V, Isfort S, von Tresckow J, Fink AM, Buhler A, Winkler D, Kreuzer KA, Staib P, Ritgen M, Kneba M, Dohner H, Eichhorst BF, Hallek M, Stilgenbauer S, Wendtner CM. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012 Sep 10;30(26):3209-16. doi: 10.1200/JCO.2011.39.2688. Epub 2012 Aug 6.
- Results publicationObrtlikova P, Spacek M, Doubek M, Hadrabova M, Panovska A, Svackova K, Trneny M. Bendamustine with rituximab (BR) is safe treatment option with high response rate for chronic lymphocytic leukemia in elderly patients with comorbidities. LEUKEMIA & LYMPHOMA 56(1SI): 151-153, 2015 [abstract #180].
- Results publicationSpacek M, Obrtlikova P, Hadrabova M, Cmunt E, Karban J, Molinsky J, Simkovic M, Mocikova H, Mohammadova L, Panovska A, Novak J, Smolej L, Doubek M, Trneny M. Observational study in comorbid patients with CLL receiving first-line rituximab-bendamustine. XVII International Workshop on CLL, New York, May 12-15, 2017 [abstract #148]
- Derived from this study: PubMed 30797139Spacek M, Obrtlikova P, Hrobkova S, Cmunt E, Karban J, Molinsky J, Simkovic M, Mocikova H, Mohammadova L, Panovska A, Novak J, Trneny M, Smolej L, Doubek M. Prospective observational study in comorbid patients with chronic lymphocytic leukemia receiving first-line bendamustine with rituximab. Leuk Res. 2019 Apr;79:17-21. doi: 10.1016/j.leukres.2019.02.002. Epub 2019 Feb 15.
- Czech CLL Study GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Martin Spacek, MD, PhD study chair
Czech CLL Study Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Czech CLL Study Group at 5 sites in Czechia.
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 1 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Toxicity assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) criteria (time frame: 8 months). 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?
On the ClinicalTrials.gov record for NCT02381899, which also lists 4 linked publications.
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 1 Feb 2019.