Clinical trial NCT00517049: A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)
Official title: A Phase II, Single-Arm, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of Multiple Doses of PRO95780 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: NHL
Rituxan
Lymphoma
CD20-positive
B-Cell
APM4083g
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase II, single-arm, open-label, multicenter trial is designed to evaluate the safety, efficacy, and pharmacokinetics of PRO95780 when combined with rituximab in patients with follicular, CD20-positive B-cell NHL that has progressed following previous rituximab therapy.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥ 18 years
* Diagnosis of follicular, CD20-positive B-cell 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

Exclusion Criteria:

* 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
* 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/TRAIL

Primary outcomes:
measure: Objective response, as determined by independent review facility
timeFrame: 8 months
Secondary outcomes:
measure: Progression-free survival, as determined by independent review facility
timeFrame: up to 12 months
measure: Duration of objective response, as determined by independent review facility
timeFrame: up to 10.3 months
measure: Overall survival
timeFrame: Up to 18.5 months
measure: Objective response, as determined by the investigator
timeFrame: Up to 8 months
measure: Progression-free survival, as determined by the investigator
timeFrame: Up to 18.5 months
measure: Duration of objective response, as determined by the investigator
timeFrame: Up to 14.1 months
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Gordon Bray, M.D.
role: STUDY_DIRECTOR
References: