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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate defined as partial and complete responses. For CLL this will be defined using the NCI-WG Response Criteria for CLL and for SLL using the IWG revised response criteria for malignant lymphoma

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Bruce Cheson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Georgetown University

Authority:

United States: Food and Drug Administration

Study ID:

OB2009-315

NCT ID:

NCT01010568

Start Date:

April 2010

Completion Date:

July 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • CLL
  • SLL
  • Bendamustine
  • Ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Georgetown UniversityWashington, District of Columbia  20007-2197