Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders
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|ClinicalTrials.gov Identifier: NCT00071396|
Recruitment Status : Completed
First Posted : October 22, 2003
Results First Posted : February 25, 2011
Last Update Posted : August 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Campath-1H Drug: Rituximab||Phase 2|
- To determine the efficacy and response rates of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in the treatment of chronic lymphoid disorders that are refractory to conventional therapy, have relapsed, or have no established frontline therapy.
- To assess the safety of the combination of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in chronic lymphoid disorders that express both CD52 and CD20 cell surface antigens.
- To measure levels of soluble (s) CD20 and sCD52 as well as levels of Campath-1H, rituximab and antibody complexes of rituximab/CD20 and Campath-1H/CD52 in patients with chronic lymphoid disorders treated with Campath-1H plus rituximab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||August 2007|
Experimental: Campath-1H + Rituximab
Campath 15 mg/day continuous intravenous (IV) infusion x 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.
Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22.
15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
375 mg/m^2 IV infusion on day 1, then 500 mg/m^2 on days 8, 15, and 22.
Other Name: Rituxan
- Overall Response [ Time Frame: After each 4 week course of treatment ]Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071396
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli, MD||M.D. Anderson Cancer Center|