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

This study has been withdrawn prior to enrollment.
(PI left institution)
Sponsor:
Collaborators:
Cephalon
GlaxoSmithKline
Information provided by:
Nevada Cancer Institute
ClinicalTrials.gov Identifier:
NCT01131247
First received: May 25, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Drug: ofatumumab + bendamustine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

Resource links provided by NLM:


Further study details as provided by Nevada Cancer Institute:

Primary Outcome Measures:
  • Overall Response Rate/ Efficacy [ Designated as safety issue: No ]
    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:
  • Safety Evaluation [ Designated as safety issue: Yes ]
    The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.

  • Response Rate [ Designated as safety issue: No ]
    Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy

  • Correlative Analysis [ Designated as safety issue: No ]
    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


Estimated Enrollment: 37
Arms Assigned Interventions
Experimental: ofatumumab + bendamustine 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.
Other Names:
  • Ofatumumab / Brand: Arzerra
  • Bendamustine / Brand: Treanda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131247

Locations
United States, Arizona
Mayo Clinic
PHoenix/Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Nevada Cancer Institute
Cephalon
GlaxoSmithKline
Investigators
Principal Investigator: Mark Kirschbaum, MD Nevada Cancer Institute
Principal Investigator: Jose Leis, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark Kirschbaum, MD, Nevada Cancer Institute
ClinicalTrials.gov Identifier: NCT01131247     History of Changes
Other Study ID Numbers: NVCI 09-15, 18083/6265
Study First Received: May 25, 2010
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Nevada Cancer Institute:
CLL
bendamustine
ofatumumab
blood cancer
leukemia
lymphoma
lymphocyte
refractory
Advanced
relapsed
hematologic
hematology
antibody
non-Hodgkin lymphoma
small lymphocytic lymphoma
nevada cancer institute
cephalon
Glaxosmithkline

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014