Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: FilgrastimBiological: PegfilgrastimBiological: Rituximab
- Registration Number
- NCT00101010
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rituximab - Combination Chemotherapy Pegylated liposomal doxorubicin hydrochloride Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Rituximab - Combination Chemotherapy Filgrastim Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Rituximab - Combination Chemotherapy Pegfilgrastim Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Rituximab - Combination Chemotherapy Rituximab Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Rituximab - Combination Chemotherapy Vincristine Sulfate Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Rituximab - Combination Chemotherapy Cyclophosphamide Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses. Rituximab - Combination Chemotherapy Prednisone Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.
- Primary Outcome Measures
Name Time Method Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses Evaluation after 12 weeks (4 cycles of 21 days) Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT \& FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver \& spleen, \& all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic \& liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow.
Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses Up to 24 weeks (8 cycles of 21 days) Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0.
- Secondary Outcome Measures
Name Time Method Survival Rate 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 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.
Trial Locations
- Locations (7)
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Hematology Oncology Associates of Central New York, PC - Northeast Center
🇺🇸East Syracuse, New York, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
University of Texas M.D. Anderson CCOP Research Base
🇺🇸Houston, Texas, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States