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Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborators:
GlaxoSmithKline
Cephalon
Information provided by:
Nevada Cancer Institute
ClinicalTrials.gov Identifier:
NCT01125787
First received: May 14, 2010
Last updated: July 19, 2011
Last verified: July 2011

May 14, 2010
July 19, 2011
May 2010
August 2010   (final data collection date for primary outcome measure)
Overall Response Rate (Efficacy) [ Designated as safety issue: No ]
The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.
Same as current
Complete list of historical versions of study NCT01125787 on ClinicalTrials.gov Archive Site
  • Safety Evaluation [ Designated as safety issue: Yes ]
    1) evaluating the toxicity of patients treated with bendamustine and ofatumumab
  • Response Rate Evaluation [ Designated as safety issue: No ]
    evaluate complete response rate, progression- free survival, overall survival, and time to next therapy
  • Correlative Analysis [ Designated as safety issue: No ]
    determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.
Same as current
Not Provided
Not Provided
 
Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab
PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

Investigational Drug:

Ofatumumab (Azerra)

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.

Participation:

Approximately 38 previously untreated 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia (CLL)
Drug: ofatumumab + bendamustine
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.
Other Names:
  • Generic: Ofatumumab Brand: Arzerra
  • Generic: Bendamustine Brand: Treanda
Experimental: ofatumumab + bendamustine
Intervention: Drug: ofatumumab + bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2011
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be >/= 18 years old and able to provide consent
  • Must have diagnosis of CLL as defined by NCI criteria
  • Must be previously untreated for CLL
  • Must require chemotherapy
  • 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)
  • Performance status 0-2
  • Women of child bearing age must be willing to use accepted/effective method of birth control.

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125787
NVCI 09-14, C18083/6264
Yes
Mark Kirschbaum, MD, Nevada Cancer Institute
Nevada Cancer Institute
  • GlaxoSmithKline
  • Cephalon
Principal Investigator: Mark Kirschbaum, MD Nevada Cancer Institute
Nevada Cancer Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP