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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title:

PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01125787
• Other study ID #: NVCI 09-14
• Secondary ID: C18083/6264
• Status: Terminated
• Phase: Phase 2
• First received: May 14, 2010
• Last updated: July 19, 2011
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2011
• Source: Nevada Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Nevada Cancer Institute	Las Vegas	Nevada

Sponsors (3)

Lead Sponsor	Collaborator
Nevada Cancer Institute	Cephalon, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (Efficacy)	The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.		No
Secondary	Safety Evaluation	1) evaluating the toxicity of patients treated with bendamustine and ofatumumab		Yes
Secondary	Response Rate Evaluation	evaluate complete response rate, progression- free survival, overall survival, and time to next therapy		No
Secondary	Correlative Analysis	determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.		No