Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00101010|
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : September 11, 2014
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer 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 cancer-killing substances to them. 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. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: Filgrastim Biological: Pegfilgrastim Biological: Rituximab Drug: Cyclophosphamide Drug: Pegylated liposomal doxorubicin hydrochloride Drug: Prednisone Drug: Vincristine Sulfate||Phase 2|
- Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
- Determine the cardiotoxicity and myelosuppression of this regimen in these patients.
- Determine disease-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||September 2014|
Experimental: Rituximab - Combination Chemotherapy
Rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses
5 mcg/kg, SC daily, start 24 hours after chemotherapy
Other Names:Biological: Pegfilgrastim
6 mg SC one time (24 hours after chemotherapy)
Other Names:Biological: Rituximab
375 mg/m^2 intravenous piggy back (IVPB) on day 1, administered 1st
Other Name: RituxanDrug: Cyclophosphamide
750 mg/m^2 IVPB on day 1
Other Names:Drug: Pegylated liposomal doxorubicin hydrochloride
40 mg/m^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1
Other Names:Drug: Prednisone
40 mg/m^2 oral days 1 - 5.Drug: Vincristine Sulfate
2 mg IV, day 1
- Disease response (complete, complete unconfirmed, and partial responses) after courses 4 and 8 [ Time Frame: Up to 24 weeks (8 cycles of 21 days) ]
- Cardiac toxicity as measured by LVEF on ECHO after courses 4 and 8 [ Time Frame: Up to 24 weeks (8 cycles of 21 days) ]
- Survival Rate [ Time Frame: Up to 5 years ]The percentage of participants still alive after treatment. Survival information obtained 1 month after completion of treatment, then every 3 months for 1 year, every 4 months for one year and every 6 months thereafter.
- Disease-free survival [ Time Frame: Up to 5 years or until disease progression ]The percentage of participants with no disease progression for period of time after treatment. Survival assessed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 3 years, and then yearly thereafter up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101010
|United States, Arkansas|
|Hembree Mercy Cancer Center at St. Edward Mercy Medical Center|
|Fort Smith, Arkansas, United States, 72913|
|United States, Michigan|
|CCOP - Grand Rapids|
|Grand Rapids, Michigan, United States, 49503|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Missouri|
|Cancer Research for the Ozarks|
|Springfield, Missouri, United States, 65804|
|United States, New York|
|Hematology Oncology Associates of Central New York, PC - Northeast Center|
|East Syracuse, New York, United States, 13057-4510|
|United States, South Carolina|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|United States, Texas|
|University of Texas M.D. Anderson CCOP Research Base|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Maria A. Rodriguez, MD||M.D. Anderson Cancer Center|