Leukaemia, Lymphocytic, Chronic and Lymphoma, FollicularPhase 1NCT00742144
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1 study testing ofatumumab in people with Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular, run by GlaxoSmithKline at 3 sites in Japan.
Trial summary
This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
- What is being tested?
- ofatumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesJapan
- Study dates
- 19 Sep 2008to 18 Nov 2009
- Phase
- Phase 1
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent.
- Histologically confirmed relapsed or refractory CD20 positive FL grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or CD5, CD19, CD20 and CD23 positive relapse or refractory CLL.
- Subjects must have adequate blood, liver, and kidney function.
- Subjects who passed the provided periods from the last anti-cancer treatments at screening
- ECOG Performance Status of 0-2
- Life expectancy more than 24 weeks at screening
Who cannot join
- Current and past malignancy other than FL and CLL within 5 years prior to screening.
- Known Richter's transformation
- Previous autologous stem cell transplantation within 24 weeks prior to screening
- Previous allogeneic stem cell transplantation
- Known CNS involvement
- History of significant cerebrovascular disease
Show all 13Show fewer
- Current cardiac disease requiring medical treatment
- Chronic or ongoing active infectious disease requiring systemic treatment
- Patients with pleural effusion or ascites detectable by physical examination
- Positive serology test for any of HBsAg, anti-HBc or anti-HCV
- Known HIV positive
- Pregnant or lactating women
- Women of childbearing potential and male patients not willing to use adequate contraception
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
GSK Investigational Site
Aichi, 466-8650
GSK Investigational Site
Tokyo, 104-0045
GSK Investigational Site
Tokyo, 135-8550
About this study
Official title: An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.
- Being tested
- ofatumumab
- Keywords
- CD20 positive, Chronic lymphocytic leukemia, Follicular lymphoma, GSK1841157, Japanese patient, Ofatumumab
- Medical subject headings
- Leukemia, Bronchiolitis Obliterans Syndrome, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofatumumabDrug
Ofatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL.
| Study group | Role | What they receive |
|---|---|---|
| ofatumumab | Experimental | Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia Receives: Drug: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerability
Measured: eight weeks
Secondary outcomes (1)
Adverse event,Clinical laboratory tests,Immunoglobulin,HAHA,Objective response rate,Duration of response,Progression free survival,CD5,19,20,CD23 positive cells,Complement (CH50),PK parameters,
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study start19 Sep 2008
- Primary completion18 Nov 2009
- Study completion18 Nov 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 Leukaemia, Lymphocytic, Chronic and Lymphoma, FollicularStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742144
- Sponsor's protocol ID
- OMB111148
- Status last verified
- Nov 2017
- First submitted
- 26 Aug 2008
- Last updated
- 17 Nov 2017
- Results posted
- No
Publications
Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Jewell RC, Katsura K, Hotta T. Phase I study of ofatumumab, a human anti-CD20 antibody, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Jpn J Clin Oncol. 2013 May;43(5):466-75. doi: 10.1093/jjco/hyt022. Epub 2013 Feb 28.
PubMed 23456745
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Study of Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00742144
- Acronym / sponsor ID
- OMB111148
- Keywords
- CD20 positive, Chronic lymphocytic leukemia, Follicular lymphoma, GSK1841157, Japanese patient, Ofatumumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2008 (actual)
- Primary completion
- 18 Nov 2009 (actual)
- Study completion
- 18 Nov 2009 (actual)
- First posted
- 27 Aug 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.
This is an open-label study to evaluate safety, tolerability, efficacy and PK profile of ofatumumab monotherapy in Japanese follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL) patients. subject will receive ofatumumab 8 weekly infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ofatumumab | Experimental | Drug: ofatumumabJapanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent.
- Histologically confirmed relapsed or refractory CD20 positive FL grade 1-3a and 1 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or CD5, CD19, CD20 and CD23 positive relapse or refractory CLL.
- Subjects must have adequate blood, liver, and kidney function.
- Subjects who passed the provided periods from the last anti-cancer treatments at screening
- ECOG Performance Status of 0-2
Key exclusion criteria (13 listed)
- Current and past malignancy other than FL and CLL within 5 years prior to screening.
- Known Richter's transformation
- Previous autologous stem cell transplantation within 24 weeks prior to screening
- Previous allogeneic stem cell transplantation
- Known CNS involvement
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 |
|---|---|---|
| ofatumumabOfatumumab (GSK1841157), a clear colorless liquid, is supplied in a glass vial. Each vial contains 100mg of ofatumumab in 5mL. | Drug | ofatumumab |
Primary outcome
tolerability
Time frame: eight weeks
1 secondary outcome
Adverse event,Clinical laboratory tests,Immunoglobulin,HAHA,Objective response rate,Duration of response,Progression free survival,CD5,19,20,CD23 positive cells,Complement (CH50),PK parameters,
Time frame: nine months
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 17 Nov 2017.
- Background: PubMed 23456745Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Jewell RC, Katsura K, Hotta T. Phase I study of ofatumumab, a human anti-CD20 antibody, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Jpn J Clin Oncol. 2013 May;43(5):466-75. doi: 10.1093/jjco/hyt022. Epub 2013 Feb 28.
- Results for study OMB111148 can be found on the GSK Clinical Study Register.Link 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.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ofatumumab in people with Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular, run by GlaxoSmithKline at 3 sites in Japan.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
tolerability (time frame: eight weeks). 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 NCT00742144, 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 17 Nov 2017.