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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01010568
• Other study ID #: OB2009-315
• Status: Terminated
• Phase: Phase 2
• First received: October 19, 2009
• Last updated: November 10, 2015
• Start date: April 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Ofatumumab and Bendamustine
Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	Cephalon, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia	6 months	No
Secondary	Complete Response Rate	NCI IWG response criteria	6 months	No
Secondary	Median PFS	Kaplan Meyer PFS	2 years	No