Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00794820
First received: November 18, 2008
Last updated: April 7, 2014
Last verified: April 2014

November 18, 2008
April 7, 2014
December 2003
November 2015   (final data collection date for primary outcome measure)
Efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00794820 on ClinicalTrials.gov Archive Site
Remission duration and survival. [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
To evaluate remission duration and survival. [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline
Fludarabine, Cyclophosphamide, and Multiple Dose Rituximab as Frontline Therapy in Chronic Lymphocytic Leukemia (CLL)

Primary Objective:

  • To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.

Secondary Objective:

  • To evaluate remission duration and survival.

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a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
  • Drug: Fludarabine Phosphate
    25 mg/m^2 by vein over 5-30 minutes daily for 3 days (days 2-4)
    Other Names:
    • Fludara®
    • Fludarabine
  • Drug: Cyclophosphamide
    250 mg/m^2 by vein over 60 minutes daily for 3 days (days 2-4)
    Other Names:
    • Cytoxan®
    • Neosar®
  • Drug: Rituximab
    375 mg/m^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m^2 on days 2-3
    Other Name: Rituxan®
Experimental: FCR-Multiple Dose Rituximab
Fludarabine phosphate + Cyclophosphamide + Rituximab
Interventions:
  • Drug: Fludarabine Phosphate
  • Drug: Cyclophosphamide
  • Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
November 2015
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 16 years or older
  2. Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month of steroids or chemotherapy) are eligible
  3. Performance status of 3 or better (Appendix A)
  4. Adequate renal and hepatic function (creatinine <2 mg%, bilirubin <2mg%). Patient with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman but upper limits for creatinine even under these circumstances would be creatinine < 3 mg% and bilirubin < 6 mg%. Patients with Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%..
  5. A signed informed consent in keeping with policies of the hospital

Exclusion Criteria:

1) None

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00794820
2003-0591, NCI-2010-01220
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Genentech, Inc.
Principal Investigator: Susan O'Brien, M.D. M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP