NCT01010568

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 15, 2015

Completed
Last Updated

December 15, 2015

Status Verified

September 1, 2015

Enrollment Period

4.1 years

First QC Date

October 19, 2009

Results QC Date

July 22, 2015

Last Update Submit

November 10, 2015

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Keywords

CLLSLLBendamustineOfatumumab

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia

    6 months

Secondary Outcomes (2)

  • Complete Response Rate

    6 months

  • Median PFS

    2 years

Study Arms (1)

Ofatumumab and Bendamustine

EXPERIMENTAL

Ofatumumab and Bendamustine

Drug: Ofatumumab and Bendamustine

Interventions

Ofatumumab and BendamustineDRUG

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

Also known as: Bendamustine, Treanda, Ofatumumab
Ofatumumab and Bendamustine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (1)

  • 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.

    PMID: 24925211DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ofatumumabBendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Bruce D. Cheson
Organization
Georgetown University Hospital
bdc4@georgetown.edu
202-444-1212

Study Officials

  • Bruce Cheson, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

November 10, 2009

Study Start

April 1, 2010

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

December 15, 2015

Results First Posted

December 15, 2015

Record last verified: 2015-09

Locations

US(1)