Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
|ClinicalTrials.gov Identifier: NCT01258933|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2010
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: Ofatumumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)|
|Actual Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Ofatumumab 300 mg dose 1, then 1,000 mg weekly * 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance.
300 mg Dose 1, then 1,000 mg weekly x 7, (treatment) then 1,000 mg every 2 months beginning on week 12
Other Name: Arzerra
- Number of Patients with Objective Response [ Time Frame: Week 12 ]Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.
- Time-to-Treatment Failure (TTF) [ Time Frame: Start of study drug up to 2 years ]TTF assessed according to the 2008 IWCLL recommendations.
- Progression-Free Survival (PFS) [ Time Frame: Start of study drug up to 2 years ]PFS assessed according to the 2008 IWCLL recommendations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258933
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William G Wierda, MD||M.D. Anderson Cancer Center|