NCT01131247

Brief Summary

Investigational Drugs: Ofatumumab (Azerra) + bendamustine (Trenda) Route of Administration: Intravenous (IV) Hypothesis: This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL. Participation: Approximately 37 relapsed/refractory CLL subjects will participate in this study over two years. Treatment Plan: A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only. Follow-up: Patients will be followed monthly for six months, then every three months for five years then annually thereafter.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

First QC Date

May 25, 2010

Last Update Submit

July 19, 2011

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

CLLbendamustineofatumumabblood cancerleukemialymphomalymphocyterefractoryAdvancedrelapsedhematologichematologyantibodynon-Hodgkin lymphomasmall lymphocytic lymphomanevada cancer institutecephalonGlaxosmithkline

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate/ Efficacy

    The primary objective for this trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.

Secondary Outcomes (3)

  • Safety Evaluation

  • Response Rate

  • Correlative Analysis

Study Arms (1)

ofatumumab + bendamustine

EXPERIMENTAL
Drug: ofatumumab + bendamustine

Interventions

ofatumumab + bendamustineDRUG

Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.

Also known as: Ofatumumab / Brand: Arzerra, Bendamustine / Brand: Treanda
ofatumumab + bendamustine

Eligibility Criteria

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

You may qualify if:

  • Must be \>/= 18 years old and able to provide consent
  • Must have diagnosis of CLL as defined by NCI criteria
  • Must require chemotherapy
  • Must be previously treated with a minimum of one course of prior chemo or other treatment
  • Serum creatinine \<1.8 mg/dl
  • Bilirubin must be \</= 2 mg/d, unless secondary to tumor
  • Must have adequate liver function (as defined as \<2x ULN, unless related to CLL)
  • AST/ALT \<2x ULN
  • Performance status 0-2
  • Women of child bearing age must be willing to use accepted/effective method of birth control.

You may not qualify if:

  • Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.
  • Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • Not have history of corticosteroid treatment for CLL
  • Not have CNS disease
  • Not have clinically significant infections
  • Patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible.
  • Not have positive serology for Hepatitis B or Hepatitis C
  • Not have be known to be HIV positive
  • Not have New York Classification III or IV hear disease
  • Other protocol specific criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

PHoenix/Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellHematologic NeoplasmsLeukemiaLymphomaRecurrenceLymphoma, Non-Hodgkin

Interventions

ofatumumabBendamustine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mark Kirschbaum, MD

    Nevada Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Jose Leis, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 26, 2010

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)