LeukemiaPhase 2NCT00939328
S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment
A Phase 2 study testing rituximab and bendamustine hydrochloride in people with Leukemia, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine, 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 cell growth in different ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- rituximab and bendamustine hydrochloride
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2010
- 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:
- Histologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)
- Progressive or symptomatic disease
- Purine analog-refractory disease
- Must meet 1 of the following criteria:
- Intermediate- or high-risk modified-Rai stage
- Low-risk modified-Rai stage and progressive lymphocytosis, defined as > 50% increase of absolute peripheral lymphocyte count over the lowest count during the past 2 months
- Received 1 or more prior therapies for CLL
- Must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients"
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-3
- ANC > 1,000/mm³
- Platelet count > 50,000/mm³
- Serum creatinine ≤ 2 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No systemic fungal, bacterial, viral, or other infection that is not controlled (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 5 years
- HIV positivity allowed provided the following criteria are met:
- CD4 cells > 350/mm³
- No concurrent antiretroviral therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior chemotherapy, any other investigational agents, or major surgery
- More than 120 days since prior allogeneic or autologous hematopoietic stem cell transplantation
- If prior allogeneic bone marrow transplantation, must meet the following criteria:
- Performed > 120 days ago
- No acute graft-vs-host disease (GVHD) ≥ grade 2
- Receiving no immunosuppressive therapy for chronic GVHD
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent CYP1A2 inhibitors
About this study
Official title: S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as bendamustine, 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 cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving bendamustine together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving bendamustine together with rituximab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia that has not responded to previous treatment.
Read the detailed description
OBJECTIVES:
- To test whether the response rate (CR, CRi, or PR) in patients with purine analog-refractory, B-cell chronic lymphocytic leukemia (CLL) after treatment with the combination of bendamustine hydrochloride and rituximab is sufficiently high to warrant further investigation.
- To evaluate the safety and tolerability of bendamustine hydrochloride and rituximab in patients with B-cell CLL who are refractory to treatment with a purine-nucleoside analog-containing regimen.
- To investigate, in a preliminary manner, the prognostic effects of pre-treatment cytogenetic abnormalities identified by conventional cytogenetics and by FISH analyses on response to treatment in this patient population.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1 and bendamustine IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. In course 1 only, patients also receive rituximab IV on day 2.
After completion of study treatment, patients are followed up periodically for 2 years.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
bendamustine hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (CR, CRi, or PR)
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: question was no longer committee priority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matt E. Kalaycio, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939328
- Sponsor's protocol ID
- S0902
- Other IDs
- S0902, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 14 Jul 2009
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00939328
- Acronym / sponsor ID
- S0902
- Conditions
- Leukemia
- Keywords
- B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: question was no longer committee priority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Jul 2009 (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, 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 cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving bendamustine together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving bendamustine together with rituximab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia that has not responded to previous treatment.
Detailed description
OBJECTIVES:
- To test whether the response rate (CR, CRi, or PR) in patients with purine analog-refractory, B-cell chronic lymphocytic leukemia (CLL) after treatment with the combination of bendamustine hydrochloride and rituximab is sufficiently high to warrant further investigation.
- To evaluate the safety and tolerability of bendamustine hydrochloride and rituximab in patients with B-cell CLL who are refractory to treatment with a purine-nucleoside analog-containing regimen.
- To investigate, in a preliminary manner, the prognostic effects of pre-treatment cytogenetic abnormalities identified by conventional cytogenetics and by FISH analyses on response to treatment in this patient population.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1 and bendamustine IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. In course 1 only, patients also receive rituximab IV on day 2.
After completion of study treatment, patients are followed up periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| rituximab | Biological | – |
| bendamustine hydrochloride | Drug | – |
Primary outcome
Response rate (CR, CRi, or PR)
Safety and tolerability
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Matt E. Kalaycio, MD study chair
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab and bendamustine hydrochloride in people with Leukemia, run by SWOG Cancer Research Network.
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: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Response rate (CR, CRi, or PR). 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?
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 6 Mar 2015.