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

Condition(s) targeted: Chronic Lymphocytic Leukemia (CLL)

Intervention: ofatumumab + bendamustine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Nevada Cancer Institute

Official(s) and/or principal investigator(s):
Kenneth Foon, MD, Principal Investigator, Affiliation: Nevada Cancer Institute

Overall contact:
Elizabeth Hutchins, Study Coordinator, Phone: 702-822-5375, Email: ehutchins@nvcancer.org

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 39 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.

Official title: PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATON OF BENDAMUSTINE AND OFATUMUMAB

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

Primary outcome: Overall Response Rate (Efficacy)

Secondary outcome:

Safety Evaluation

Response Rate Evaluation

Correlative Analysis

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- 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 thromboctopenia

- 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 Hepatits C

- Not have be known to be HIV positive

- Not have New York Classification III or IV hear disease

Elizabeth Hutchins, Study Coordinator, Phone: 702-822-5375, Email: ehutchins@nvcancer.org

University of Florida, Gainesville, Florida 32610, United States; Not yet recruiting
Kellie Ritari, Study Coordinator, Email: ritari@ufl.edu
Nam Dang, MD, PhD, Sub-Investigator, Phone: 352-273-9103
Nam Dang, MD, PhD, Sub-Investigator

Nevada Cancer Institute, Las Vegas, Nevada 89135, United States; Recruiting
Elizabeth Hutchings, Study Coordinator, Phone: 702-822-5375, Email: ehutchings@nvcancer.org
Kenneth Foon, MD, Principal Investigator, Phone: 702-822-5433
Kenneth Foon, MD, Principal Investigator

Visit Nevada Cancer Institute Website for more information on investigator or trial

Starting date: May 2010
Last updated: May 17, 2010