A PHASE II, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED 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
- Conditions
- Follicular, CD20-Positive B-Cell Non-Hodgkin's LymphomaMedDRA version: 9.1Level: LLTClassification code 10029593Term: Non-Hodgkin's lymphoma NOS
- Registration Number
- EUCTR2007-001666-32-GB
- Lead Sponsor
- Genentech Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
>Signed Informed Consent Form
> Age =18 years
>Diagnosis of follicular, CD20-positive B-cell NHL classified as Grade 1, 2, or
3a according to the WHO classification of malignant lymphomas
>Progression of disease after an objective response (CR/CRu or PR) or SD according to revised IWG criteria lasting 6 months following completion of the most recent rituximab-containing regimen
>A rituximab-containing regimen is defined as rituximab as a single agent
during induction and/or maintenance, or in combination with other agents.
>Measurable disease (according to modified IWG Criteria; see Appendix B)
ECOG performance status of 0 or 1 (see Appendix D)
>Life expectancy of 3 months
>Willingness and capability to be accessible for follow-up until study
termination or death
>For patients of reproductive potential (both males and females), use of a
reliable means of contraception (e.g., contraceptive pill, intrauterine device
[IUD], barrier methods) throughout the trial and for 1 year following their last
exposure to study treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
>Grade 3b follicular lymphoma (according to the 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
(i.e., =50% increase in the product of the longest perpendicular diameters of
the lesion [greatest transverse diameter perpendicular diameter] when
compared with the nadir of lesion dimensions following radiotherapy and
1.5 cm in the greatest transverse diameter)
>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
> Patients who received prior radio-immunotherapy for relapsed or refractory follicular NHL at least 1 year prior to first administration of study drug (i.e, rituximab) may participate if they meet minimal study requirements for peripheral blood counts (see below) and do not demonstrate evidence of myelodyplastic syndrome (MDS) on their screening bone marrow biopsy (as evidenced by cytogenetic or FISH criteria).
>Concurrent systemic corticosteroid therapy (except low-dose corticosteroid
therapy used to treat an illness other than lymphoma or single doses of up to 100mg hydrocortisone, administered as prophylaxis against rituximab-mediated infusion reactions)
>Other invasive malignancies within 3 years prior to first study drug administration (i.e, rituximab) except for adequately treated (with curative intent) 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 three years.
>History or evidence on physical examination of central nervous system
(CNS) disease (e.g., primary brain tumor, CNS lymphoma, seizures not
controlled with standard medical therapy, any brain metastases, or history
of stroke)
>Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL
>General Medical Concerns
>Current or recent (within the 28 days prior to Cycle 1, Day 1) participation in
another experimental drug study
>Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
myocardial infarction within 1 year prior to Cycle 1, Day 1, unstable angina),
New York Heart Association (NYHA; see Appendix E) Grade II or greater
congestive heart failure, serious cardiac arrhythmia requiring medication
within 1 year prior to Cycle1, Day 1, or Grade II or greater peripheral vascular
disease (see Appendix F) at study entry
>Active infection requiring parenteral antibiotics on Cycle 1, Day 1
Protocol: Apomab—Genentech,
>Major surgical procedure (excluding lymph node biopsy) or significant
traumatic injury within 28 days prior to Cycle 1, Day 1, or anticipation of need
for major surgical procedure during the course of the study
>Pregnancy (positive pregnancy test) or breast feeding
>Serious, non-healing wound, ulcer, or bone fracture
Laboratory values
ANC 1500/L (may not be treated with G-CSF to maintain or exceed
this level) Platelet count 75,000/L Total bilirubin1.6 mg/dL AST or ALT 2.5 the upper limit of normal (ULN) Serum creatinine 2.0 mg/dL or measured creatinine clearance
=50 mL/min Hemoglobin 9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level)
>Known human immunodeficiency virus (HIV) infection, seropositivi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method