Chronic Lymphocytic LeukemiaPhase 2NCT00758693
Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia, run by University of Kentucky at 1 site in United States.
Trial summary
Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Bendamustine and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed chronic lymphocytic leukemia.
- A minimum of any one of the following disease-related symptoms must be present:
- Weight loss ≥10% within the previous 6 months.
- Extreme fatigue (ie, ECOG PS 2; cannot work or unable to perform usual activities).
- Fevers of greater than 100.5"F for ≥ 2 weeks without evidence of infection.
- Night sweats without evidence of infection. or
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- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia or
- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy or
- Massive (ie, >6 cm below the left costal margin) or progressive splenomegaly or
- Massive nodes or clusters (ie, > 10 cm in longest diameter) or progressive lymphadenopathy or
- Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months but
- Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy
- No prior therapy for CLL is allowed. Participants may have taken corticosteroids previously but must be ≥ 28 days from last dose prior to enrolment.
- Age >65 years.
- Life expectancy of greater than 1 year.
- ECOG performance status better than or equal 2.
- Patients must have normal organ and marrow function as defined below:
- total bilirubin within normal institutional limits unless resulting from documented hemolysis
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had previous chemotherapy or radiotherapy for the treatment of CLL.
- Patients may not be receiving any other investigational agents.
- Patients with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bendamustine or rituximab.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Patients with a known history of viral hepatitis, with the exception of Hepatitis A that has recovered.
- Patients who require concomitant treatment with CYP1A2 inhibitors including: Cimetidine, Ciprofloxacin, Fluvoxamine, Ticlopidine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia: A Phase II Study
Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Bendamustine, Rituximab
- Keywords
- Chronic Lymphocytic Leukemia, Bendamustine, Treanda, Rituximab, Rituxan
- 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.
BendamustineDrug
Also called Treanda
Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles
RituximabDrug
Also called Rituxan
Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bendamustine + Rituximab Receives: Drug: Bendamustine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the response rate
Measured: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL
Secondary outcomes (4)
Describe the toxicity rates and severities
Measured: Up to 2 years after enrollment
Describe the quality of life participants experience while receiving this combination therapy
Measured: Up to 2 years after enrollment
Determine the health utility scores of participants while receiving this combination therapy
Measured: Up to 2 years after enrollment
Conduct exploratory analyses of associations between clinical responses and protein expression and phosphorylation using novel flow cytometry methods
Measured: Pre and Post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Funding was withdrawn due to insufficient accrual
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- John Hayslip, MD, MSCR, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758693
- Sponsor's protocol ID
- 08-LEUK-07-MCC/CI
- Status last verified
- Sep 2011
- First submitted
- 19 Sep 2008
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia: A Phase II Study
- ClinicalTrials.gov ID
- NCT00758693
- Acronym / sponsor ID
- 08-LEUK-07-MCC/CI
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Bendamustine, Treanda, Rituximab, Rituxan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was withdrawn due to insufficient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Sep 2008 (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.
Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bendamustine, Drug: RituximabBendamustine + Rituximab |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (22 listed)
- Patients must have histologically or cytologically confirmed chronic lymphocytic leukemia.
- A minimum of any one of the following disease-related symptoms must be present:
- No prior therapy for CLL is allowed. Participants may have taken corticosteroids previously but must be ≥ 28 days from last dose prior to enrolment.
- Age >65 years.
- Life expectancy of greater than 1 year.
Key exclusion criteria (8 listed)
- Patients who have had previous chemotherapy or radiotherapy for the treatment of CLL.
- Patients may not be receiving any other investigational agents.
- Patients with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bendamustine or rituximab.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| BendamustineAlso: TreandaBendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles | Drug | 1 |
| RituximabAlso: RituxanRituximab 500 mg/m2 on a 28-day cycle for 6 cycles | Drug | 1 |
Primary outcome
Determine the response rate
Time frame: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL
4 secondary outcomes
Describe the toxicity rates and severities
Time frame: Up to 2 years after enrollment
Describe the quality of life participants experience while receiving this combination therapy
Time frame: Up to 2 years after enrollment
Determine the health utility scores of participants while receiving this combination therapy
Time frame: Up to 2 years after enrollment
Conduct exploratory analyses of associations between clinical responses and protein expression and phosphorylation using novel flow cytometry methods
Time frame: Pre and Post treatment
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 11 Jan 2012.
- Markey Cancer Center Blood and Marrow Transplant Study SearchLink provided by the sponsor.
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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.
John Hayslip, MD, MSCR principal investigator
University of Kentucky
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 Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia, run by University of Kentucky at 1 site in United States.
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 22 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Jan 2012. 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 United States. 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 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?
Determine the response rate (time frame: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL). 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 11 Jan 2012.