Chronic Lymphocytic LeukemiaPhase 2NCT00274963
Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 2 study testing bendamustine hydrochloride and mitoxantrone hydrochloride in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 12 sites in Germany.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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 hydrochloride and mitoxantrone hydrochloride
- How many people
- 60 participants
- Where
- 12 sitesGermany
- Study dates
- Oct 2004to Oct 2009
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Cytologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)
- Relapsed or refractory disease
PATIENT CHARACTERISTICS:
- No known hypersensitivity to any of the study medications
- No uncontrolled infection
- No impaired organ function
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Humaine - Clinic
Bad Saarow, 15526
Schwerpunktpraxis fuer Haematologie und Internistische Onkologie
Berlin, D-10117
Praxis Fuer Haematologie Internistische Onkologie
Cologne, D-50677
Internistische Gemeinschaftspraxis - Halle
Halle, 06110
St. Marien Hospital
Hamm, 59065
Praxis fuer Haematologie und Onkologie
Koblenz, D-56068
Haematologische / Onkologische Schwerpunktpraxis
Krefeld, 47798
Internistische Onkologische Praxis - Kronach
Kronach, 96317
Internistische Praxis - Neuss
Neuss, 41460
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, 26121
Haematologische Praxis
Weiden, D-92637
Deutsche Klinik fuer Diagnostik
Wiesbaden, D-65191
About this study
Official title: Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)
RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bendamustine together with mitoxantrone works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate (remission rate) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with bendamustine and mitoxantrone hydrochloride.
Secondary
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive bendamustine IV over 1 hour on days1-3 and mitoxantrone hydrochloride IV over 30 minutes on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease (i.e., complete response or partial response) after 2 courses receive 2 additional courses of treatment for a total of 4 courses.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total 60 patients will be accrued for this study.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- bendamustine hydrochloride, mitoxantrone hydrochloride
- Keywords
- B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia
- 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 hydrochlorideDrug
mitoxantrone hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall remission rate (partial and complete remission)
Secondary outcomes (3)
Time to progression
Safety and tolerability
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startOct 2004
- Primary completionNov 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German CLL Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Hubert Koeppler, MD, Study chair, Praxis fuer Haematologie und Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274963
- Sponsor's protocol ID
- CLL2K
- Other IDs
- EU-20551, RIBOSEPHARM-GCLLSK-CLL2K
- Status last verified
- May 2018
- First submitted
- 10 Jan 2006
- Last updated
- 11 May 2018
- Results posted
- No
Publications
Koppler H, Fuss H, Hurtz HJ, Knigge O, Losem C, Reschke D, Schmitz S, Weide R, Weiss J, Hallek M; GCLLSG. Bendamustine plus mitoxantrone for relapsed/refractory chronic lymphocytic leukaemia (CLL): results of a multicentre phase II study of the German CLL Study Group (GCLLSG). Br J Haematol. 2012 Jul;158(2):238-241. doi: 10.1111/j.1365-2141.2012.09132.x. Epub 2012 May 10.
PubMed 22571691
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM)
- ClinicalTrials.gov ID
- NCT00274963
- Acronym / sponsor ID
- CLL2K
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- German CLL Study GroupUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Jan 2006 (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.
RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bendamustine together with mitoxantrone works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate (remission rate) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with bendamustine and mitoxantrone hydrochloride.
Secondary
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive bendamustine IV over 1 hour on days1-3 and mitoxantrone hydrochloride IV over 30 minutes on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease (i.e., complete response or partial response) after 2 courses receive 2 additional courses of treatment for a total of 4 courses.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 hydrochloride | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
Primary outcome
Overall remission rate (partial and complete remission)
3 secondary outcomes
Time to progression
Safety and tolerability
Overall survival
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 11 May 2018.
- Results publication: PubMed 22571691Koppler H, Fuss H, Hurtz HJ, Knigge O, Losem C, Reschke D, Schmitz S, Weide R, Weiss J, Hallek M; GCLLSG. Bendamustine plus mitoxantrone for relapsed/refractory chronic lymphocytic leukaemia (CLL): results of a multicentre phase II study of the German CLL Study Group (GCLLSG). Br J Haematol. 2012 Jul;158(2):238-241. doi: 10.1111/j.1365-2141.2012.09132.x. Epub 2012 May 10.
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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.
Hubert Koeppler, MD study chair
Praxis fuer Haematologie und Onkologie
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bendamustine hydrochloride and mitoxantrone hydrochloride in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 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.
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?
Overall remission rate (partial and complete remission). 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 NCT00274963, which also lists 1 linked publication.
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 11 May 2018.