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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response, as determined by independent review facility

Outcome Time Frame:

8 months

Safety Issue:

No

Principal Investigator

Gordon Bray, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

APM4083g

NCT ID:

NCT00517049

Start Date:

March 2008

Completion Date:

December 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • NHL
  • Rituxan
  • Lymphoma
  • CD20-positive
  • B-Cell
  • APM4083g
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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