Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Phase 2

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Interventions: Drug: Ofatumumab and Bendamustine

• Registration Number: NCT01010568
• Lead Sponsor: Georgetown University

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-19
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Study Start: 2010-04
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Results First Submitted: 2015-07-22
• Status Verified: 2015-09
• Results First Submitted QC: 2015-11-10
• Last Update Submitted: 2015-11-10
• Results First Posted: 2015-12-15
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Pathologically confirmed CLL or SLL requiring therapy
• Age 18 years of age or older
• ECOG performance status 0, 1, or 2
• Normal organ and bone marrow function
• Resolution of toxic effects from prior therapies
• Ability to adhere to the study schedule and give written informed consent

Exclusion Criteria

• Any serious medical, psychiatric illness or laboratory abnormality
• Chemotherapy or radiotherapy within 4 weeks of entering the study
• Currently receiving other treatment for CLL/SLL or other malignancies
• Active other malignancies
• History of allergic reactions to bendamustine or ofatumumab
• Ongoing corticosteroid use
• Pregnant or lactating
• HIV positive
• Active hepatitis B
• Allogeneic transplant within 6 months of entering study or graft-versus-host disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ofatumumab and Bendamustine	Ofatumumab and Bendamustine	Ofatumumab and Bendamustine

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	6 months	40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate	6 months	NCI IWG response criteria
Median PFS	2 years	Kaplan Meyer PFS

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States