A Phase 2 interventional study of pegfilgrastim and rituximab in Lymphoma, sponsored by Cancer Research UK. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-08-26.
Sponsored by Cancer Research UK · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with diffuse large B-cell non-Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1 and 11 and CODOX-M comprising doxorubicin hydrochloride IV on day 1, cyclophosphamide IV on days 1-5, vincristine sulfate IV on days 1 and 8, methotrexate IV over 12 hours on day 10, and leucovorin calcium IV or orally every 3-6 hours beginning 24-36 hours after methotrexate. Patients also receive CNS prophylaxis comprising cytarabine intrathecally (IT) on days 1 and 3 and methotrexate IT on day 15. Patients with high-risk disease receive an additional dose of cytarabine IT on day 5 and methotrexate IT on day 17. Patients also receive pegfilgrastim subcutaneously (SC) on day 11. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of CODOX-M course 1, patients receive rituximab IV on day 1** and IVAC comprising etoposide phosphate IV over 1 hour and ifosfamide IV over 1 hour on days 1-5, cytarabine IV over 3 hours (every 12 hours) on days 1 and 2, and methotrexate IT on day 5. Patients with high-risk disease receive cytarabine IT on days 7 and 9. Patients also receive pegfilgrastim SC on day 7. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
NOTE: **Patients with high-risk disease also receive rituximab IV on days 21 and 42 after day 1 of course 4 (IVAC).
Treatment with R-CODOX-M and R-IVAC repeats every 28 days alternatively for 2 courses each in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Cancer Research UK is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma
International Prognostic Index (IPI) score high-intermediate (score = 3) OR high (score = 4 or 5), defined as:
No history of treated or non-treated indolent lymphoma
PATIENT CHARACTERISTICS:
LVEF ≥ 50% and only tested if patient meets 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
Complete response rate
Toxicity
Progression-free survival
This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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