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

Primary Purpose

Chronic Lymphocytic Leukemia (CLL)

Status
Withdrawn
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, lymphoma, lymphocyte, refractory, Advanced, relapsed, hematologic, hematology, antibody, 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 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

Sites / Locations

  • Mayo Clinic

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 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
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

Full Information

First Posted
May 25, 2010
Last Updated
July 19, 2011
Sponsor
Nevada Cancer Institute
Collaborators
Cephalon, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01131247
Brief Title
PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nevada Cancer Institute
Collaborators
Cephalon, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

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, lymphoma, lymphocyte, refractory, Advanced, relapsed, hematologic, hematology, antibody, 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
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ofatumumab + bendamustine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ofatumumab + bendamustine
Other Intervention Name(s)
Ofatumumab / Brand: Arzerra, 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 trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.
Secondary Outcome Measure Information:
Title
Safety Evaluation
Description
The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.
Title
Response Rate
Description
Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy
Title
Correlative Analysis
Description
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

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Kirschbaum, MD
Organizational Affiliation
Nevada Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Leis, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
PHoenix/Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
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

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

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