Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma (NCT00004192) | Clinical Trial Compass
CompletedPhase 2
Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma
United States60 participantsStarted 2000-05-01
Plain-language summary
RATIONALE: Colony-stimulating factors may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that of filgrastim to relieve the neutropenia following combination chemotherapy in patients who have non-Hodgkin's lymphoma.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion Criteria:
* Diagnosis of non-Hodgkin's lymphoma (NHL)
o Relapsed disease or Refractory to first line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy
* Age 18 and over
* ECOG 0-2Absolute neutrophil count at least 1,500/mm3Platelet count at least 150,000/mm3
* Creatinine not greater than 1.5 mg/dL or Creatinine clearance greater than 60 mL/min
* Fertile patients must use effective barrier contraception
* At least 4 weeks since prior radiotherapy
* At least 72 hours since prior antimicrobials
* At least 30 days since other prior investigational drug
Exclusion Criteria:
* No myelodysplastic syndrome or chronic myeloid leukemia
* Not pregnant or nursing/Negative pregnancy test
* No other prior malignancy except
* Curatively treated basal cell or squamous cell carcinoma
* Carcinoma in situ of the cervix
* Surgically cured malignancy
* No hypersensitivity to E. coli derived products (e.g., filgrastim (G-CSF), insulin, asparaginase)
* No prior bone marrow or peripheral blood stem cell (PBSC) transplantation for NHL
* No prior filgrastim-SD/01
* No other concurrent myelopoietic growth factors
* No concurrent WBC transfusions
* No concurrent PBSC collection
* No more than 2 prior courses of chemotherapy for any malignancy
* No concurrent corticosteroids except topical steroids or as pre-medications or associated with chemotherapy
* No other concurrent investigational drug
* No concurrent prophylactic antibiotics during course 1