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 range19 Years
SexALL
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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…
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Up to 90 days after the last dose of study drugs