|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genentech |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00794820 |
Purpose
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide and high-dose rituximab will improve the remission rate and the length of remissions in patients with CLL.
Optional Procedures: You may be asked to have extra blood drawn. This will be used to measure levels of rituximab in the blood, to see whether antibodies to rituximab are forming, and to measure levels of certain proteins. You will also be asked to allow testing to be done on the bone marrow sample that was performed already, as well as on future bone marrows that will be done to evaluate your response to treatment. These tests on the bone marrow sample are being done to find out if certain protein levels are related to how you respond to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Fludarabine Phosphate Drug: Cyclophosphamide Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Fludarabine, Cyclophosphamide, and Multiple Dose Rituximab as Frontline Therapy in Chronic Lymphocytic Leukemia (CLL) |
| Enrollment: | 66 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Fludarabine phosphate + Cyclophosphamide + Rituximab
|
Drug: Fludarabine Phosphate
Fludarabine phosphate 25 mg/m^2 IV over 5-30 minutes daily x 3 (days 2-4)
Drug: Cyclophosphamide
Cyclophosphamide 250 mg/m^2 IV over 60 minutes daily x 3 (days 2-4)
Drug: Rituximab
Rituximab 375 mg/m^2 for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m^2 on days 2-3
|
DESCRIPTION OF RESEARCH
Fludarabine and cyclophosphamide are chemotherapy drugs that are used in the treatment of CLL. Rituximab is a monoclonal antibody that binds to lymphoma cells and causes cell death.
Before treatment starts, you will have a complete physical exam and routine blood tests (about 2 teaspoons). A bone marrow sample will be 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. Women who are able to have children must have a negative blood or urine pregnancy test.
Rituximab will be given through a needle (IV) in a vein on Days 1, 2, and 3. One day after the first dose of rituximab (Day 2), fludarabine and cyclophosphamide will be given through a needle (IV) in a vein daily for 3 days (Days 2, 3, 4). After the first month, all the drugs will be given on Days 1, 2, 3. Other IV fluids such as saline will be given on all of the treatment days for hydration, which means that the daily visit will take about six hours. The combination will be repeated once every 4 to 6 weeks for a total of 6 courses.
The drugs acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl) will be given before the dose of rituximab. This will be done to decrease the risk of side effects. If side effects do occur during rituximab treatment, the drug may have to be stopped until the side effects go away and then restarted so the time in the outpatient area may be longer.
The first treatment will be given at M. D. Anderson. The other 5 courses can be performed ether at M. D. Anderson or at home with your regular physician.
The same doses of all three drugs will be used throughout the study unless side effects become severe. In that case, the dose may be lowered or the treatment may be stopped. You will be taken off study if the disease gets worse.
During treatments, patients will have blood samples (about 1 teaspoon each) taken once every 1-2 weeks. Bone marrow studies will be done at the end of the 3rd and 6th chemotherapy courses.
After treatment is completed, you will have blood tests (about 2 teaspoons each) done every 3 months for as long as you are in remission.
This is an investigational study. The FDA has approved all of the drugs used in this study and they are commercially available. However, their use in this study is investigational. As many as 64 patients will take part in the study. All will be enrolled at M. D. Anderson.
Optional Procedures: If you agree, you will have 6-8 teaspoons of blood drawn before the start of therapy and then 1-2 teaspoons of blood drawn on your return visits every 3 months for 1 year. Special tests will be done on your bone marrow. The bone marrow will be performed anyway to evaluate your response to the treatment.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Susan O'Brien, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Susan O'Brien MD/Professor ) |
| Study ID Numbers: | 2003-0591 |
| Study First Received: | November 18, 2008 |
| Last Updated: | November 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00794820 |
| Health Authority: | United States: Institutional Review Board |
|
Chronic Lymphocytic Leukemia CLL Leukemia Fludarabine phosphate Cyclophosphamide |
Rituximab FCR Cytoxan® Neosar® Rituxan® |
|
Chronic lymphocytic leukemia Vidarabine Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Cyclophosphamide |
Fludarabine monophosphate Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |
