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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title:

PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01131247
• Other study ID #: NVCI 09-15
• Secondary ID: 18083/6265
• Status: Withdrawn
• Phase: Phase 2
• First received: May 25, 2010
• Last updated: July 19, 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 37
• 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 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: 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	Mayo Clinic	PHoenix/Scottsdale	Arizona

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 trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.		No
Secondary	Safety Evaluation	The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.		Yes
Secondary	Response Rate	Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy		No
Secondary	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		No