Clinical trial NCT00496873
Conditions: Lymphoma
Keywords: Non-Hodgkin's Lymphoma NHL Lymphoma B-cell chronic lymphocytic leukemia SLL Small Lymphocytic Lymphoma Lymphoplasmacytic lymphoma/immunocytoma Follicular lymphoma Extranodal marginal zone B-cell lymphoma of MALT type Nodal marginal zone B-cell lymphoma Chronic Lymphocytic Leukemia CLL Bulky Lymphoma Nipent Cytoxan Rituxan Cyclophosphamide Rituximab Pentostatin
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-06-01; Completion date: 2014-12-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the clinical research study is to learn if treatment with a combination of three drugs, Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin), will help to control the disease in patients with previously untreated non-Hodgkin's lymphoma, CLL, or bulky lymphoma. The safety of this treatment will also be studied.

Detailed description:
All of the drugs \[Cytoxan (cyclophosphamide), Rituxan (rituximab) and Nipent (pentostatin)\] in this study are commonly used in the treatment of this cancer. However, using these drugs in combination is investigational.

Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. You will have blood collected (around 2-3 tablespoons) for routine tests. You will have a chest x-ray and CT scans of the chest, abdomen (stomach), and pelvis (waist area). Tumors will be measured using x-rays. You will have a sample of bone marrow collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. If your doctor feels it is necessary, you may also have lymph node biopsy samples taken for special tests. Women who are able to have children must have a negative blood or urine pregnancy test.

During treatment you will be given a combination of three drugs in a 21 day (3 weeks) cycle. All drugs will be given through a needle in a vein over 4-6 hours. You will receive pentostatin first, then rituximab, and lastly cyclophosphamide. For each treatment cycle cyclophosphamide, rituximab, and pentostatin will be given on Day 1, followed by 20 days of rest.

During treatment, you will have around 2-3 tablespoons of blood collected at least once a week for routine tests. You will also provide a urine sample for routine urine tests. Depending on how the disease responds, treatment may be stopped after 3, 6, or 9 cycles. You will be taken off treatment if your disease gets worse. If your treatment is delayed for more than 2 weeks due to any side effect related to the treatment or for more than 3 weeks for any reason, you will be taken off of this study. If your doctor feels that you are having serious or intolerable side effects that are not improved by standard supportive care methods (such as medicine to control nausea or a transfusion to treat anemia) you will be taken off of this study.

After Cycles 3, 6, and 9, tumors will be measured using x-rays or other scans (CT or MRI). Bone marrow samples will be taken if they are needed to find out if the drug combination is working to control your disease.

The maximum number of cycles that you can receive is 9. If you wish to continue using this drug treatment, and it is beneficial to do so, you may continue to receive these drugs. However, these drugs are commercially available, so you will be financially responsible for the cost of these drugs.

After you receive the last cycle of chemotherapy, your doctor will decide your schedule of follow-up exams. You will have follow-up exams every 3 months for one year, every 6 months for 2nd year, then once after 1 year. During these exams, you will have a chest x-ray and CT scans of the chest, abdomen (stomach), and pelvis (waist area). You will also have blood collected (2-3 tablespoons) for routine tests.

This is an investigational study. All of the study drugs are approved by the FDA for cancer treatment and are commercially available. However, the use of the drugs in combination is investigational. Up to 100 patients will take part in this study. All enrolled will be at M. D. Anderson.

Arms: arm 1: Cytoxan 600 mg/m\^2 on Day 1 of 21-day cycle. Rituxan 375 mg/m\^2 on Day 1 of 21 Day Cycle. Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Interventions: intervention 1: Cytoxan intervention 2: Nipent intervention 3: Rituxan
Intervention descriptions: intervention 1: 600 mg/m\^2 on Day 1 of 21-day cycle. intervention 2: 4 mg/m\^2 on Day 1 of 21 Day Cycle. intervention 3: 375 mg/m\^2 on Day 1 of 21 Day Cycle.

Protocol documents: