Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in… (NCT01329900) | Clinical Trial Compass
CompletedPhase 2
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
United States50 participantsStarted 2011-08-22
Plain-language summary
The goal of this clinical research study is to learn if it is possible to collect stem cells after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects, number of stem cells collected, and the number of procedures that are needed to collect enough stem cells.
Who can participate
Age range
18 Years – 70 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
. Patients with histologically confirmed CD20 positive B-cell NHL who are candidates for autologous SCT.
. Patients must have PR to salvage chemotherapy.
. Age 18-70 years.
. Platelet count \>/= 100,00 mm³ independent of transfusion support.
. Absolute neutrophil count \>/= 1500/mm³.
. Zubrod performance status (PS) 2 or less.
. Negative serum pregnancy test in women of childbearing potential. This is a female who has not been postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization.
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.
. Less than 5% marrow involvement with NHL within 4 weeks of study as defined by unilateral bone marrow aspiration and biopsy.
Exclusion criteria
. Subjects who have current active hepatic ( (HbsAg, HbcAb, and positive viral load by PCR) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) with ALT \> 2x upper limit of normal or bilirubin \> 1.5. (Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.)
. Active CNS disease.
. Severe concomitant medical or psychiatric illness.