Prolymphocytic LeukemiaPhase 2NCT00281931
Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia
A Phase 2 study testing rituximab, cyclophosphamide and fludarabine phosphate in people with Prolymphocytic Leukemia, run by German CLL Study Group at 1 site in Germany.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prolymphocytic Leukemia
- What is being tested?
- rituximab, cyclophosphamide and fludarabine phosphate
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Sep 1999to Oct 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of B-cell prolymphocytic leukemia
- Previously treated disease
- All Binet stages allowed
PATIENT CHARACTERISTICS:
- Life expectancy > 3 months
- ECOG/WHO performance status 0-3
PRIOR CONCURRENT THERAPY:
- No more than 3 prior treatment regimens
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine, cyclophosphamide, and rituximab.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6. Treatment repeats every 28 days for up to 6 courses.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
- Conditions
- Prolymphocytic Leukemia
- Being tested
- rituximab, cyclophosphamide, fludarabine phosphate
- Keywords
- prolymphocytic leukemia
- Medical subject headings
- Leukemia, Prolymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
cyclophosphamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Progression-free survival
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startSep 1999
- Primary completionApr 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolymphocytic 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
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German CLL Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Michael Herold, MD, PhD, Study chair, HELIOS Hospital, Erfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281931
- Sponsor's protocol ID
- PLL1
- Other IDs
- EU-20563
- Status last verified
- Sep 2016
- First submitted
- 24 Jan 2006
- Last updated
- 26 Sep 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
- ClinicalTrials.gov ID
- NCT00281931
- Acronym / sponsor ID
- PLL1
- Conditions
- Prolymphocytic Leukemia
- Keywords
- prolymphocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- German CLL Study GroupUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Apr 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 25 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 fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.
Detailed description
OBJECTIVES:
- Determine the overall and progression-free survival of patients with B-cell prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine, cyclophosphamide, and rituximab.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive rituximab IV on day 0 in course 1 and on day 1 in courses 2-6. Treatment repeats every 28 days for up to 6 courses.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- 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 |
|---|---|---|
| rituximab | Biological | – |
| cyclophosphamide | Drug | – |
| fludarabine phosphate | Drug | – |
Primary outcome
Overall survival
Progression-free survival
Toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- 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.
Michael Herold, MD, PhD study chair
HELIOS Hospital, Erfurt, 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 study testing rituximab, cyclophosphamide and fludarabine phosphate in people with Prolymphocytic Leukemia, run by German CLL Study Group 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?
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: stopped early, as of the sponsor's last update on 26 Sep 2016. 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 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 was stopped early. 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?
Overall survival. The study lists 3 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 26 Sep 2016.