Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00005601
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine response rate to cisplatin, cytarabine, and dexamethasone (DHAP) plus rituximab in patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma.
* Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen.
* Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen.
OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study within 11 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description rituximab+dexamethasone+cisplatin+cytarabine+sargramostim rituximab Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. rituximab+dexamethasone+cisplatin+cytarabine+sargramostim cytarabine Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. rituximab+dexamethasone+cisplatin+cytarabine+sargramostim dexamethasone Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. rituximab+dexamethasone+cisplatin+cytarabine+sargramostim cisplatin Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. rituximab+dexamethasone+cisplatin+cytarabine+sargramostim sargramostim Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
- Primary Outcome Measures
Name Time Method response Up to 5 years
- Secondary Outcome Measures
Name Time Method overall survival Up to 5 years percentage of patients able to proceed to transplant after two courses of this treatment regimen Up to 5 years duration of response Up to 5 years
Trial Locations
- Locations (21)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Scroll for more (11 remaining)CCOP - Scottsdale Oncology Program🇺🇸Scottsdale, Arizona, United States