Chronic Lymphocytic LeukemiaPhase 2/3NCT01423032
Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
A Phase 2/3 study testing bendamustine and Fludarabine in people with Chronic Lymphocytic Leukemia, run by WiSP Wissenschaftlicher Service Pharma GmbH at 1 site in Germany.
Trial summary
Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine. 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 Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2001to May 2009
- Phase
- Phase 2/3
- 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
Who may be able to join
- histologically or immunologically confirmed chronic B-cell leukemia
- refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
- disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
- negative pregnancy test/ adequate method of contraception
Who cannot join
- T-CLL, PLL (prolymphocytic leukemia)
- presence of Richter's transformation
- first-line treatment containing either fludarabine or bendamustine
- acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
- secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Prof. Dr. Norbert Niederle
Leverkusen, North Rhine-Westphalia, D-51375
About this study
Official title: Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.
Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- bendamustine, Fludarabine
- Keywords
- relapsed
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustineDrug
100 mg/m² iv, day 1+2, q4w
FludarabineDrug
25 mg/m² iv, days 1-5, q4w
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine | Experimental | Not described Receives: Drug: bendamustine |
| Fludarabine | Active comparator | Not described Receives: Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
Measured: the patients were followed on average for 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startSep 2001
- Primary completionMay 2009
- Study completionMay 2009
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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- WiSP Wissenschaftlicher Service Pharma GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Leverkusen gGmbH, ribosepharm GmbH, Mundipharma Research GmbH & Co KG
- Responsible party
- Sponsor
- Investigators
- Norbert Niederle, Prof, MD, Study chair, Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423032
- Sponsor's protocol ID
- WISP_RI05
- Status last verified
- Aug 2011
- First submitted
- 19 Aug 2011
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
- ClinicalTrials.gov ID
- NCT01423032
- Acronym / sponsor ID
- WISP_RI05
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- relapsed
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- WiSP Wissenschaftlicher Service Pharma GmbHUniversity, hospital or other
- Collaborators
- Klinikum Leverkusen gGmbH, ribosepharm GmbH, Mundipharma Research GmbH & Co KG
- Study start
- Sep 2001
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Aug 2011 (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.
Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to its unique mechanism of action distinct from standard alkylating agents. This study assesses its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in comparison to fludarabine.
Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine 100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of 25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior progression-free survival with bendamustine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bendamustine | Experimental | Drug: bendamustine |
| Fludarabine | Active comparator | Drug: Fludarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically or immunologically confirmed chronic B-cell leukemia
- refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen
- disease stage II-IV according to Rai or B/C according to Binet staging system, respectively
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better
- negative pregnancy test/ adequate method of contraception
Key exclusion criteria (5 listed)
- T-CLL, PLL (prolymphocytic leukemia)
- presence of Richter's transformation
- first-line treatment containing either fludarabine or bendamustine
- acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders
- secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)
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 |
|---|---|---|
| bendamustine100 mg/m² iv, day 1+2, q4w | Drug | Bendamustine |
| Fludarabine25 mg/m² iv, days 1-5, q4w | Drug | Fludarabine |
Primary outcome
progression-free survival
Time frame: the patients were followed on average for 36 months
individual time-frame up to max. follow-up (Kaplan-Meier estimation)
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 25 Aug 2011.
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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.
Norbert Niederle, Prof, MD study chair
Med. Klinik III, Klinikum Leverkusen gGmbH, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bendamustine and Fludarabine in people with Chronic Lymphocytic Leukemia, run by WiSP Wissenschaftlicher Service Pharma GmbH at 1 site in Germany.
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 5 inclusion and 5 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 25 Aug 2011. 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
progression-free survival (time frame: the patients were followed on average for 36 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 25 Aug 2011.