A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
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|ClinicalTrials.gov Identifier: NCT00858117|
Recruitment Status : Active, not recruiting
First Posted : March 9, 2009
Last Update Posted : February 6, 2018
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving alemtuzumab together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: Alemtuzumab Biological: Rituximab||Phase 2|
- To determine the response rate in patients with previously untreated B-cell chronic lymphocytic leukemia treated with alemtuzumab and rituximab.
- To evaluate the toxicity of alemtuzumab and rituximab in these patients.
OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease progression or unacceptable toxicity.
Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20, CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.
After completion of study treatment, patients are followed periodically for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Alemtuzumab and Rituximab
Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.
Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks
Other Name: Campath-1H
Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks
Other Name: Rituxan
- To determine the response rate to the study medications, Alemtuzumab and Rituximab [ Time Frame: At 9 weeks (during therapy), 18 weeks (at the completion of therapy), and 30 weeks ]Response rate to the study medications, Alemtuzumab and Rituximab, will be measured at 9 weeks, 18 weeks, and 30 weeks, by physical examination and evaluation of peripheral blood and bone marrow through lab tests.
- Collect data on the toxicity of the study medications, Alemtuzumab and Rituximab [ Time Frame: Every 2 weeks while on treatment and then monthly for 6 months, then every 3 months for 4.5 years (54 months) ]Toxicity data of the study medications, Alemtuzumab and Rituximab will be evaluated by blood tests every 2 weeks while on treatment and then monthly for 6 months, then every 3 months for 4.5 years (54 months)
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): NCT00858117
|United States, Illinois|
|Northwestern University, Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Olga Frankfurt, MD||Northwestern University|