Chronic Lymphocytic LeukemiaNCT03847727
Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (PFS) with the previous regimen. 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?
- BR as Maintenance
- How many people
- 112 participants
- Where
- 1 siteRussia
- Study dates
- 3 Dec 2013to 3 Dec 2020
- 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 relapsed or refractory CLL receiving treatment at the University Hematology Hospital and Ambulant clinic.
Who may be able to join
- Confirmed diagnosis of CD20-positive CLL that meets the iwCLL criteria (Hallek et al, 2008).
- Relapsed or refractory status of disease after at least one prior chemotherapy regimen.
- ECOG performance status of 0-2 at study entry
- Patients have not received prior therapy with bendamustine
- Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.
- For inclusion in the research part of maintenance therapy (phase B):
- At least a partial response (PR or better; Hallek et al, 2008) must be achieved after induction of BR (phase A)
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment.
- Pregnant or breast-feeding females.
- Known to be positive for human immunodeficiency virus (HIV) or infectious hepatitis (type B or C).
- Patients are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement.
- Richter syndrome or chronic prolymphocytic leukemia.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
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- Concurrent use of other anti-cancer agents or treatments.
- Laboratory test results within these ranges: ANC ≤ 1000/μL, Platelet count ≤ 75,000/μL.
- Total bilirubin Total bilirubin ≥ 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
- Serum transaminases AST (SGOT) and ALT (SGPT) ≥ 3 x ULN, and/or serum alkaline phosphatase ≥ 5 X ULN.
- New York Heart Association class 3-4 heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Bendamustine and Rituximab as Induction Immunochemotherapy Followed by Maintenance Bendamustine and Rituximab in Relapsed and Refractory B-cell Chronic Lymphocytic Leukemia (CLL)
CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (PFS) with the previous regimen. Bendamustine and rituximab (BR) is one of the most widely adopted CIT regimens, including second-line treatment. Unfortunately, durations of remission following BR combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. The incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- BR as Maintenance
- Keywords
- Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Rituximab, Maintenance
- 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.
BR as MaintenanceDrug
Patients of the study group who have achieved at least a partial response after 6 cycles of BR induction will receive additionally 4 cycles of BR every 3 months as maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 6 cycles BR -> 4 x BR | Induction plus BR as maintenance (N=56) Receives: Drug: BR as Maintenance | |
| Proper historical control: 6 cycles BR | Induction only (N=56) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS is defined as the number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of disease progression or death, whichever occurs first. PFS will be compared with its proper historical control (BR as induction without subsequent maintenance).
Measured: 42 months
Secondary outcomes (4)
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission [nPR] plus partial remission [PR]) per the 2008 Modified IWCLL NCI-WG criteria.
Measured: Approximately 24 months after initial dose of study drug.
Overall Survival (OS)
OS is defined as number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of death.
Measured: 60 months (6 months induction therapy, 12 months maintenance, 42 months long-term follow-up
Safety evaluations
To determine the safety and tolerability of induction chemotherapy and maintenance therapy separately for two groups as assessed by CTCAE v4.0:
Measured: Up to 30 months
Health Related Quality of Life (HRQoL)
To determinate the effect of maintenance therapy on HRQoL using the EORTC Core quality of life questionnaire (QOL-C30, version 3.0).
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start3 Dec 2013
- Primary completion3 Dec 2019
- Study completion3 Dec 2020 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey Semochkin, Professor, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847727
- Sponsor's protocol ID
- RSMU-CLL-2013
- Status last verified
- Dec 2019
- First submitted
- 15 Jan 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bendamustine and Rituximab as Induction Immunochemotherapy Followed by Maintenance Bendamustine and Rituximab in Relapsed and Refractory B-cell Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT03847727
- Acronym / sponsor ID
- RSMU-CLL-2013
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Rituximab, Maintenance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2020 (estimated)
- First posted
- 20 Feb 2019 (actual)
- 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.
CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patients who attained a long progression-free survival (PFS) with the previous regimen. Bendamustine and rituximab (BR) is one of the most widely adopted CIT regimens, including second-line treatment. Unfortunately, durations of remission following BR combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. The incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 6 cycles BR -> 4 x BR | – | Drug: BR as MaintenanceInduction plus BR as maintenance (N=56) |
| Proper historical control: 6 cycles BR | – | –Induction only (N=56) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsed or refractory CLL receiving treatment at the University Hematology Hospital and Ambulant clinic.
Key inclusion criteria (7 listed)
- Confirmed diagnosis of CD20-positive CLL that meets the iwCLL criteria (Hallek et al, 2008).
- Relapsed or refractory status of disease after at least one prior chemotherapy regimen.
- ECOG performance status of 0-2 at study entry
- Patients have not received prior therapy with bendamustine
- Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.
Key exclusion criteria (11 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment.
- Pregnant or breast-feeding females.
- Known to be positive for human immunodeficiency virus (HIV) or infectious hepatitis (type B or C).
- Patients are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement.
- Richter syndrome or chronic prolymphocytic leukemia.
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 |
|---|---|---|
| BR as MaintenancePatients of the study group who have achieved at least a partial response after 6 cycles of BR induction will receive additionally 4 cycles of BR every 3 months as maintenance therapy. | Drug | Experimental: 6 cycles BR -> 4 x BR |
Primary outcome
Progression-free survival
Time frame: 42 months
PFS is defined as the number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of disease progression or death, whichever occurs first. PFS will be compared with its proper historical control (BR as induction without subsequent maintenance).
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Approximately 24 months after initial dose of study drug.
Overall Survival (OS)
Time frame: 60 months (6 months induction therapy, 12 months maintenance, 42 months long-term follow-up
Safety evaluations
Time frame: Up to 30 months
Health Related Quality of Life (HRQoL)
Time frame: Up to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Sergey Semochkin, Professor principal investigator
Pirogov Russian National Research Medical University
1 site 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 Pirogov Russian National Research Medical University at 1 site in Russia.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Results are not available in the source record.
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?
Progression-free survival (time frame: 42 months). 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 18 Jan 2020.