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

NCT01125787 | Terminated Phase 2 DMC

• 2 other identifiers: NVCI 09-14C18083/6264
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

CLL; bendamustine; ofatumumab; blood cancer; leukemia; lymphocyte; hematology; non-Hodgkin lymphoma; small lymphocytic lymphoma; nevada cancer institute; cephalon; Glaxosmithkline

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Safety Evaluation

• Response Rate Evaluation

• Correlative Analysis

Study Arms (1)

ofatumumab + bendamustine

EXPERIMENTAL

Drug: ofatumumab + bendamustine

Interventions

ofatumumab + bendamustine DRUG

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: Generic: Ofatumumab Brand: Arzerra, Generic: Bendamustine Brand: Treanda

ofatumumab + bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

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

Sponsors & Collaborators

• Nevada Cancer Institute: lead
• GlaxoSmithKline: collaborator
• Cephalon: collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Related Links

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

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms; Leukemia; Lymphoma, Non-Hodgkin

Interventions

ofatumumab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Lymphoma

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark Kirschbaum, MD

  Nevada Cancer Institute

  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 14, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (2)