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

Primary Purpose

Chronic Lymphocytic Leukemia (CLL)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ofatumumab + bendamustine
Sponsored by
Nevada Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring CLL, bendamustine, ofatumumab, blood cancer, leukemia, lymphocyte, hematology, non-Hodgkin lymphoma, small lymphocytic lymphoma, nevada cancer institute, cephalon, Glaxosmithkline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida
  • Nevada Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ofatumumab + bendamustine

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

Safety Evaluation
1) evaluating the toxicity of patients treated with bendamustine and ofatumumab
Response Rate Evaluation
evaluate complete response rate, progression- free survival, overall survival, and time to next therapy
Correlative Analysis
determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.

Full Information

First Posted
May 14, 2010
Last Updated
July 19, 2011
Sponsor
Nevada Cancer Institute
Collaborators
GlaxoSmithKline, Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT01125787
Brief Title
Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combination of Bendamustine and Ofatumumab
Official Title
PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nevada Cancer Institute
Collaborators
GlaxoSmithKline, Cephalon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL)
Keywords
CLL, bendamustine, ofatumumab, blood cancer, leukemia, lymphocyte, hematology, non-Hodgkin lymphoma, small lymphocytic lymphoma, nevada cancer institute, cephalon, Glaxosmithkline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ofatumumab + bendamustine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ofatumumab + bendamustine
Other Intervention Name(s)
Generic: Ofatumumab Brand: Arzerra, Generic: Bendamustine Brand: Treanda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate (Efficacy)
Description
The primary objective for this study is to evaluate the overall response rate of bendamustine and ofatumumab in patients with previously untreated CLL.
Secondary Outcome Measure Information:
Title
Safety Evaluation
Description
1) evaluating the toxicity of patients treated with bendamustine and ofatumumab
Title
Response Rate Evaluation
Description
evaluate complete response rate, progression- free survival, overall survival, and time to next therapy
Title
Correlative Analysis
Description
determine whether the expression of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 </= 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Kirschbaum, MD
Organizational Affiliation
Nevada Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nevadacancerinstitute.org/
Description
Visit Nevada Cancer Institute Website for more information on investigator or trial

Learn more about this trial

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

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