Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000627358
Ethics application status
Approved
Date submitted
24/06/2008
Date registered
12/12/2008
Date last updated
12/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
APO2L/TRAIL in Combination With Rituximab in Subjects Non-Hodgkin's Lymphoma
Scientific title
A Study of APO2L/TRAIL in Combination With Rituximab as a potential treatment in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas
Secondary ID [1] 589 0
Nil
Universal Trial Number (UTN)
Trial acronym
APO3585g Apo2L/Trail
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 3904 0
Condition category
Condition code
Cancer 3465 3465 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will recieve Rituximab administered by IV infusion at 375 mg/m2 weekly for up to eight doses. Subjects randomized to the combination arm will also receive a maximum of four 21-day 8.0 mg/kg/day cycles of Apo2L/TRAIL (recombinant human Apo2 ligand/tumor necrosis factor-related apoptosis-inducing ligand), by IV infusion.
Intervention code [1] 3631 0
Treatment: Drugs
Comparator / control treatment
Rituximab is administered by IV infusion at 375 mg/m2 weekly for up to eight doses
Control group
Active

Outcomes
Primary outcome [1] 4406 0
objective response (partial response or complete response [CR/CRu]) as determined by the independent review facility (IRF)
Timepoint [1] 4406 0
Tumor response at 6, 9, and 12 months
Secondary outcome [1] 7371 0
Progression-free survival, which is defined as the time from randomization to documented
disease progression or death, whichever occurs first.
Timepoint [1] 7371 0
at 6, 9, and 12 month assessments
Secondary outcome [2] 7372 0
Overall survival
Timepoint [2] 7372 0
36 months

Eligibility
Key inclusion criteria
Signed Informed Consent Form
Age = 18 years
History of histologically confirmed CD20+ follicular Non-Hodgkin's Lymphoma Grade 1, 2, or 3a
Progression of disease following the most recent treatment with rituximab-containing therapy that resulted in stable disease or a partial or complete response lasting = 6 months
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
For subjects of reproductive potential (males and females), use of a reliable means of contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier throughout the trial and for 1 year following their final exposure to study treatment).
Life expectancy of > 3 months
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response unless that lesion shows unequivocal progression at baseline
Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal, or pelvic field within 28 days prior to Day 1
Chemotherapy, hormonal therapy, radiotherapy, or immunotherapy within 4 weeks prior to Day 1
Patients who have received radioimmunotherapy for relapsed or refractory, follicular NHL are eligible for the study if they received this therapy at least 1 year prior to Day 1, they have adequate bone marrow function, and they have no evidence of myelodysplastic syndrome on bone marrow aspirate/biopsy
Prior treatment with Apo2L/TRAIL or an agonist antibody to DR4 or DR5
Concurrent systemic corticosteroid therapy
Evidence of clinically detectable ascites on Day 1
Other invasive malignancies within 5 years prior to Day 1
History or evidence upon physical examination of CNS disease within 1 year prior to study entry
Active infection requiring parenteral antibiotics on Day 1
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study and fine needle aspirations within 7 days prior to Day 1
Pregnancy or lactation
Serious nonhealing wound, ulcer, or bone fracture
Current or recent participation in another experimental drug study
Clinically significant cardiovascular disease
Known positive test result for HIV, hepatitis B surface antigen (sAg), hepatitis B IgG or IgM core antibody, or hepatitis C antibody
Known sensitivity to murine or human antibodies
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,NT,TAS
Recruitment postcode(s) [1] 899 0
3220
Recruitment postcode(s) [2] 900 0
3084
Recruitment postcode(s) [3] 901 0
4029
Recruitment postcode(s) [4] 902 0
6000
Recruitment postcode(s) [5] 903 0
7000
Recruitment postcode(s) [6] 904 0
3128
Recruitment postcode(s) [7] 905 0
2640
Recruitment postcode(s) [8] 906 0
3002
Recruitment outside Australia
Country [1] 1006 0
New Zealand
State/province [1] 1006 0
1023
Country [2] 1007 0
New Zealand
State/province [2] 1007 0
8001

Funding & Sponsors
Funding source category [1] 3512 0
Commercial sector/Industry
Name [1] 3512 0
Genentech
Country [1] 3512 0
United States of America
Funding source category [2] 4095 0
Commercial sector/Industry
Name [2] 4095 0
Genentech
Country [2] 4095 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Genentech
Address
1 DNA Way
South San Francisco, CA
Country
United States of America
Secondary sponsor category [1] 3688 0
None
Name [1] 3688 0
Address [1] 3688 0
Country [1] 3688 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of Apo2L/TRAIL when combined with rituximab in subjects with follicular, CD20+, B-cell NHL that has progressed following a response of = 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28696 0
Address 28696 0
Country 28696 0
Phone 28696 0
Fax 28696 0
Email 28696 0
Contact person for public queries
Name 11853 0
Gordon Bray, M.D. Genentech
Address 11853 0
1 DNA Way
South San Francisco
Country 11853 0
United States of America
Phone 11853 0
011-888-662-6728
Fax 11853 0
Email 11853 0
Genentechclinicaltrials@druginfo.com
Contact person for scientific queries
Name 2781 0
Gordon Bray, M.D. Genentech
Address 2781 0
1 DNA Way
South San Francisco
Country 2781 0
United States of America
Phone 2781 0
011-888-662-6728
Fax 2781 0
Email 2781 0
Genentechclinicaltrials@druginfo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.