Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00026351|
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : February 4, 2013
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 chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: rituximab Drug: pentostatin||Phase 2|
- Determine the response rate in patients with low-grade B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with pentostatin and rituximab.
- Determine the duration of response, median time to progression, and survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV alone on day 1 of course 1 only. Patients then receive rituximab IV and pentostatin IV on days 8, 15, and 22. An additional course with both drugs is administered on days 36, 43, and 50. Patients with progressive disease or a complete response receive no further treatment. Patients with responsive disease, but less than a complete response, receive one additional course of therapy as above.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 50 non-Hodgkin's lymphoma and 50 chronic lymphocytic leukemia patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Trial Of Pentostatin and Rituximab In Patients With Previously Treated and Untreated Low Grade B-Cell Non-Hodgkin's Lymphoma (NHL) Including Chronic Lymphocytic Leukemia (CLL)|
|Study Start Date :||December 2000|
|Study Completion Date :||June 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026351
|United States, California|
|Cancer and Blood Institute of the Desert|
|Rancho Mirage, California, United States, 92270|
|Redding Medical Center|
|Redding, California, United States, 96001|
|United States, Maryland|
|Oncology-Hematology Associates, P.A.|
|Clinton, Maryland, United States, 20735|
|United States, New York|
|North Shore Hematology/Oncology Associates, P.C.|
|East Setauket, New York, United States, 11733|
|Hematology Oncology Associates of Central New York, P.C.|
|Syracuse, New York, United States, 13210|
|Study Chair:||Judy Poehlman||Pharmatech Oncology|