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PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab

This study has been withdrawn prior to enrollment.
(PI left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131247
First Posted: May 26, 2010
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cephalon
GlaxoSmithKline
Information provided by:
Nevada Cancer Institute
May 25, 2010
May 26, 2010
July 20, 2011
Not Provided
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01131247 on ClinicalTrials.gov Archive Site
  • Safety Evaluation
    The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.
  • Response Rate
    Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy
  • Correlative Analysis
    This study also aims to determine whether expression of of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival
Same as current
Not Provided
Not Provided
 
PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab
PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:
  • Ofatumumab / Brand: Arzerra
  • 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.
 
Withdrawn
37
Not Provided
Not Provided

Inclusion Criteria:

  • 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.

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

Other protocol specific criteria may apply

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01131247
NVCI 09-15
18083/6265 ( Other Identifier: Cephalon )
Yes
Not Provided
Not Provided
Mark Kirschbaum, MD, Nevada Cancer Institute
Nevada Cancer Institute
  • Cephalon
  • GlaxoSmithKline
Principal Investigator: Mark Kirschbaum, MD Nevada Cancer Institute
Principal Investigator: Jose Leis, MD Mayo Clinic
Nevada Cancer Institute
July 2011

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