Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01243190|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2010
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Ofatumumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ofatumumab Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)|
|Actual Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Other Name: Arzerra
- Number of Patients with Complete Response (CR) [ Time Frame: 3 months ]Response assessment 3 months after last dose of Ofatumumab. 2008 International Workshop on CLL (IWCLL) update of the National Cancer Institute-sponsored Working Group (NCI-WG) outlined specific criteria of Complete Response (CR) for diagnosing CLL.
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): NCT01243190
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||William G. Weirda, MD, PhD, BS||M.D. Anderson Cancer Center|