PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab
Information source: Nevada Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia (CLL)
Intervention: ofatumumab + bendamustine (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Nevada Cancer Institute Official(s) and/or principal investigator(s): Mark Kirschbaum, MD, Principal Investigator, Affiliation: Nevada Cancer Institute Jose Leis, MD, Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response Rate/ Efficacy
Secondary outcome: Safety EvaluationResponse Rate Correlative Analysis
Eligibility
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 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
Locations and Contacts
Mayo Clinic, PHoenix/Scottsdale, Arizona 85259, United States
Additional Information
Last updated: July 19, 2011
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