Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicul… (NCT01682044) | Clinical Trial Compass
CompletedPhase 2
Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma
United States20 participantsStarted 2007-04-17
Plain-language summary
This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together with rituximab may kill more cancer cells
Who can participate
Age range
19 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:
* Untreated or relapsed/refractory follicular, SLL or MZL (i.e. no limit to number of prior treatments as long as patients meet other study criteria)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable tumor size (at least one node measuring 4 cm\^2 in bidimensional measurement)
* Expected survival of \> 6 months
* Prior rituximab or other monoclonal immunotherapy permitted and eligible for rituximab monotherapy
* Full recovery from any significant toxicity associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy
* Absolute neutrophil count \> 1.0 x 10\^9/L
* Platelets \> 50 x 10\^9/L
* Patients may receive erythropoietin growth factors to maintain adequate hemoglobin levels (\>= 8.0 mg/dl)
* Creatinine \< 1.5 x upper normal levels (UNL)
* Total bilirubin \< 1.5 mg/dL (\> 25.65 umol/L)
* Aspartate aminotransferase \< 5 x UNL
* Alkaline phosphatase \< 5 x UNL
* Informed consent approved in institutional review board (lRB)
* CD20+ B-cell lymphoma
Exclusion Criteria:
* Prior history of human immunodeficiency virus (HIV)-positivity (routine HIV testing is required pretreatment)
* Serious non-malignant disease (e.g. active uncontrolled bacterial, viral, or fungal infections) or other conditions which, in the opinion of the principal investigator would compromise other protocol objectives
* Presence of central nervous system (CNS) lymphoma
* Chemotherapy within 4 weeks of the first scheduled study treatme…
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.
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Up to 90 days after the last dose of study drugs