Chronic Lymphocytic Leukemia (CLL)Phase 2NCT01125787
Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab
A Phase 2 study testing ofatumumab + bendamustine in people with Chronic Lymphocytic Leukemia (CLL), run by Nevada Cancer Institute at 2 sites in United States.
Trial summary
Investigational Drug: Ofatumumab (Azerra) Route of Administration: Intravenous (IV) Hypothesis: This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- ofatumumab + bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Apr 2011
- 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
Who may be able to join
- Must be >/= 18 years old and able to provide consent
- Must have diagnosis of CLL as defined by NCI criteria
- Must be previously untreated for CLL
- Must require chemotherapy
- serum creatinine <1.8 mg/dl
- Bilirubin must be </= 2 mg/d, unless secondary to tumor
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- Must have adequate liver function (as defined as <2x ULN, unless related to CLL)
- Performance status 0-2
- Women of child bearing age must be willing to use accepted/effective method of birth control.
Who cannot join
- Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.
- Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia
- Not have history of corticosteroid treatment for CLL
- Not have CNS disease
- Not have clinically significant infections
- Patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible.
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- Not have positive serology for Hepatitis B or Hepatitis C
- Not have be known to be HIV positive
- Not have New York Classification III or IV hear disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32610
Nevada Cancer Institute
Las Vegas, Nevada, 89135
About this study
Official title: PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
Investigational Drug:
Ofatumumab (Azerra)
Read more
Route of Administration:
Intravenous (IV)
Hypothesis:
This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone.
Participation:
Approximately 38 previously untreated CLL subjects will participate in this study over two years.
Treatment Plan:
A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.
Follow-up:
Patients will be followed monthly for six months, then every three months for five years then annually thereafter.
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Being tested
- ofatumumab + bendamustine
- Keywords
- CLL, bendamustine, ofatumumab, blood cancer, leukemia, lymphocyte, hematology, non-Hodgkin lymphoma, small lymphocytic lymphoma, nevada cancer institute, cephalon, Glaxosmithkline
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Leukemia, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofatumumab + bendamustineDrug
Also called Generic: Ofatumumab Brand: Arzerra, Generic: Bendamustine Brand: Treanda
Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.
| Study group | Role | What they receive |
|---|---|---|
| ofatumumab + bendamustine | Experimental | Not described Receives: Drug: ofatumumab + bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (Efficacy)
The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.
Secondary outcomes (3)
Safety Evaluation
- evaluating the toxicity of patients treated with bendamustine and ofatumumab
Response Rate Evaluation
evaluate complete response rate, progression- free survival, overall survival, and time to next therapy
Correlative Analysis
determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionApr 2011
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevada Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Cephalon
- Investigators
- Mark Kirschbaum, MD, Principal investigator, Nevada Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125787
- Sponsor's protocol ID
- NVCI 09-14
- Other IDs
- C18083/6264
- Status last verified
- Jul 2011
- First submitted
- 14 May 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
- ClinicalTrials.gov ID
- NCT01125787
- Acronym / sponsor ID
- NVCI 09-14
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Keywords
- CLL, bendamustine, ofatumumab, blood cancer, leukemia, lymphocyte, hematology, non-Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nevada Cancer InstituteUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Cephalon
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 May 2010 (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.
Investigational Drug:
Ofatumumab (Azerra)
Route of Administration:
Intravenous (IV)
Hypothesis:
This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone.
Participation:
Approximately 38 previously untreated CLL subjects will participate in this study over two years.
Treatment Plan:
A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.
Follow-up:
Patients will be followed monthly for six months, then every three months for five years then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ofatumumab + bendamustine | Experimental | Drug: ofatumumab + bendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be >/= 18 years old and able to provide consent
- Must have diagnosis of CLL as defined by NCI criteria
- Must be previously untreated for CLL
- Must require chemotherapy
- serum creatinine <1.8 mg/dl
Key exclusion criteria (9 listed)
- Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.
- Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia
- Not have history of corticosteroid treatment for CLL
- Not have CNS disease
- Not have clinically significant infections
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 |
|---|---|---|
| ofatumumab + bendamustineAlso: Generic: Ofatumumab Brand: Arzerra, Generic: Bendamustine Brand: TreandaLoading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only. | Drug | ofatumumab + bendamustine |
Primary outcome
Overall Response Rate (Efficacy)
The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.
3 secondary outcomes
Safety Evaluation
Response Rate Evaluation
Correlative Analysis
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Visit Nevada Cancer Institute Website for more information on investigator or trialLink 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.
Mark Kirschbaum, MD principal investigator
Nevada Cancer Institute
2 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 ofatumumab + bendamustine in people with Chronic Lymphocytic Leukemia (CLL), run by Nevada Cancer Institute at 2 sites 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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Low enrollment). 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 Response Rate (Efficacy). 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 20 Jul 2011.