Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed Informed Consent Form
Age ≥ 18 years
History of histologically confirmed CD20+ follicular NHL 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
You may not be if
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 dulanermin 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 central nervous system (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
Clareo Health | A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas
