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

NCT ID: NCT01010568

Last Updated: 2015-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Keywords

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CLL SLL Bendamustine Ofatumumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ofatumumab and Bendamustine

Ofatumumab and Bendamustine

Group Type EXPERIMENTAL

Ofatumumab and Bendamustine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Bendamustine Treanda Ofatumumab

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Cephalon

INDUSTRY

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Cheson, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Ujjani C, Ramzi P, Gehan E, Wang H, Wang Y, Cheson BD. Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2015 Apr;56(4):915-20. doi: 10.3109/10428194.2014.933217. Epub 2014 Aug 6.

Reference Type DERIVED
PMID: 24925211 (View on PubMed)

Other Identifiers

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OB2009-315

Identifier Type: -

Identifier Source: org_study_id