Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leu… (NCT00742144) | Clinical Trial Compass
CompletedPhase 1
Ofatumumab in Japanese Patients With CD20 Positive Follicular Lymphoma or Chronic Lymphocytic Leukemia
Japan6 participantsStarted 2008-09-19
Plain-language 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.
Who can participate
Age range
20 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.