Last updated: 11/04/2018 10:06:25
Ofatumumab in Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label phase I study of Ofatumumab in Japanese patients with CD20 positive follicular lymphoma or chronic lymphocytic leukemia
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
tolerability
Timeframe: eight weeks
Secondary outcomes:
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,
Timeframe: nine months
Interventions:
Drug: ofatumumab
Enrollment:
6
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Katsura K, Jewell R, 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;43(5):466-475.
Ogura M, Hatake K, Tobinai K, Uchida T, Suzuki T, Terui Y, Yokoyama M, Maruyama D, Mori M, Katsura K, Jewell R, 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;43(5):466-475
Medical condition
Leukaemia, Lymphocytic, Chronic and Lymphoma, Follicular
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
September 2008 to November 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20 - 79 years
Accepts healthy volunteers
No
- 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.
- Current and past malignancy other than FL and CLL within 5 years prior to screening.
- Known Richter’s transformation
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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 location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-18-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study OMB111148 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website