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 range
18 Years – 120 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:
* 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
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.