- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131247
PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab
PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
PHoenix/Scottsdale, Arizona, United States, 85259
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Safety Evaluation
|
The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.
|
Response Rate
|
Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Kirschbaum, MD, Nevada Cancer Institute
- Principal Investigator: Jose Leis, MD, Mayo Clinic
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Bendamustine Hydrochloride
- Ofatumumab
- Antibodies, Monoclonal
Other Study ID Numbers
- NVCI 09-15
- 18083/6265 (Other Identifier: Cephalon)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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