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Trial registered on ANZCTR


Registration number
ACTRN12608000554369
Ethics application status
Approved
Date submitted
20/08/2008
Date registered
5/11/2008
Date last updated
25/03/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of Apomab in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy
Scientific title
A Phase II, Single-Arm, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of Multiple Doses of Apomab Administered Intravenously in Combination With Rituximab in Patients With Follicular, CD20-Positive B-Cell Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy
Secondary ID [1] 731 0
ClinicalTrials.gov
#NCT00517049
Universal Trial Number (UTN)
Trial acronym
APM4083g
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma (NHL) 3582 0
Condition category
Condition code
Cancer 3741 3741 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive Rituximab once per week for up to 8 weeks in Cycles 1-3. The first dose of Rituximab will be administered between 24 and 120 hours prior to the first dose of Apomab in Cycle 1. In Cycles 2 & 3 on Day 1, Rituximab will be administered directly prior to Apomab, without a rest period between the two treatments. All patients will receive Apomab for a total of six cycles. Each cycle lasts 21 days with a resting period built into each cycle. The length of the resting period depends on the cycle. The Apomab dose will be based on the patient's body weight at screening. The rituximab dose will be based on the patient's body surface area at screening. Both Rituximab and Apomab are administered intravenously (IV).
Intervention code [1] 3297 0
Treatment: Drugs
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4641 0
Objective response based on the results of radiographic studies and pertinent clinical data as determined using modified International Working Group (IWG) Criteria. Tumors will be evaluated for response and disease progression based on the size and quantity of the lesions as compared to baseline exams.
Timepoint [1] 4641 0
8 months
Secondary outcome [1] 7848 0
Progression-free survival, as determined by independent review facility; Overall survival, defined as the time from first Apomab exposure until death from any cause.
Timepoint [1] 7848 0
Follow-up information will be collected via telephone calls and/or clinic visits every 3 months until death, loss to follow-up, or study termination by Genentech.

Eligibility
Key inclusion criteria
Diagnosis of follicular, CD20-positive B-cell Non-Hodgkin's Lymphoma (NHL).
Progression of disease after an objective response or stable disease lasting > 6 months following completion of the most recent rituximab-containing regimen.
Measurable disease.
Life expectancy of > 3 months.
Signed Informed Consent Form.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Grade 3b follicular lymphoma (according to the World Health Organization (WHO) classification) or histologic transformation from follicular lymphoma to aggressive lymphoma.
Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline.
Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1.
Concurrent systemic corticosteroid therapy.
Other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years.
History or evidence on physical examination of central nervous system (CNS) disease
Prior treatment with agonistic DR4 or DR5 antibodies or APO2L.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1163 0
United Kingdom
State/province [1] 1163 0
Country [2] 1164 0
Spain
State/province [2] 1164 0
Country [3] 1165 0
United States of America
State/province [3] 1165 0
Country [4] 1166 0
Netherlands
State/province [4] 1166 0
Country [5] 1167 0
Belgium
State/province [5] 1167 0
Country [6] 1168 0
Switzerland
State/province [6] 1168 0
Country [7] 1169 0
Russian Federation
State/province [7] 1169 0

Funding & Sponsors
Funding source category [1] 3758 0
Commercial sector/Industry
Name [1] 3758 0
Genentech, Inc
Address [1] 3758 0
1 DNA Way
South San Francisco, CA 94080
Country [1] 3758 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc
Address
1 DNA Way
South San Francisco, CA 94080
Country
United States of America
Secondary sponsor category [1] 3583 0
None
Name [1] 3583 0
Address [1] 3583 0
Country [1] 3583 0
Other collaborator category [1] 437 0
Hospital
Name [1] 437 0
Dr. Nicholas Wickham
Address [1] 437 0
Ashford Cancer Centre
48 Marleston Avenue
Ashford SA NA 5035
Country [1] 437 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5818 0
Hunter New England HREC
Ethics committee address [1] 5818 0
Hunter New England Human Research Ethics Committee -
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 5818 0
Australia
Date submitted for ethics approval [1] 5818 0
30/06/2008
Approval date [1] 5818 0
04/07/2008
Ethics approval number [1] 5818 0
EC00403

Summary
Brief summary
Apomab is a monoclonal antibody, which is a type of protein that is normally made by the immune system to help defend the body from infection and cancer. In preclinical studies Apomab selectively induced programmed cell death, or apoptosis, in cancer cells while sparing normal cells. Apomab is being studied in this clinical trial in combination with Rituximab to evaluate whether it is safe for patients with follicular NHL and whether it can delay the further spread of follicular NHL.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28863 0
Address 28863 0
Country 28863 0
Phone 28863 0
Fax 28863 0
Email 28863 0
Contact person for public queries
Name 12020 0
Mick O'Quigley
Address 12020 0
1 DNA Way, Mailstop 45-4A
South San Francisco, CA 94080
Country 12020 0
United States of America
Phone 12020 0
650-467-3508
Fax 12020 0
650-467-2247
Email 12020 0
oquigley.michael@gene.com
Contact person for scientific queries
Name 2948 0
Gordon Bray, M.D.
Address 2948 0
1 DNA Way, Mailstop 44-3B
South San Francisco, CA 94080
Country 2948 0
United States of America
Phone 2948 0
650-467-2284
Fax 2948 0
Email 2948 0
bray.gordon@gene.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary