A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk)
- Determine the complete response rate in patients with high- or high/intermediate-risk
diffuse large B-cell lymphoma treated with CODOX-M/IVAC comprising cyclophosphamide,
doxorubicin hydrochloride, vincristine sulfate, methotrexate, ifosfamide, etoposide
phosphate, and cytarabine with rituximab.
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
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
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.
Masking: Open Label, Primary Purpose: Treatment
Complete response rate
Nottingham City Hospital NHS Trust