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A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)

Primary Purpose

Non-Hodgkin's Lymphoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

PRO95780

rituximab

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL, Rituxan, Lymphoma, CD20-positive, B-Cell, APM4083g

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Objective response, as determined by independent review facility

Secondary Outcome Measures

Progression-free survival, as determined by independent review facility

Duration of objective response, as determined by independent review facility

Overall survival

Objective response, as determined by the investigator

Progression-free survival, as determined by the investigator

Duration of objective response, as determined by the investigator

Full Information

NCT ID

NCT00517049

First Posted

August 14, 2007

Last Updated

May 31, 2017

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00517049

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 2008 (Actual)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma

Keywords

NHL, Rituxan, Lymphoma, CD20-positive, B-Cell, APM4083g

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PRO95780

Intervention Description

Intravenous repeating dose

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Description

Intravenous repeating dose

Primary Outcome Measure Information:

Title

Objective response, as determined by independent review facility

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Progression-free survival, as determined by independent review facility

Time Frame

up to 12 months

Title

Duration of objective response, as determined by independent review facility

Time Frame

up to 10.3 months

Title

Overall survival

Time Frame

Up to 18.5 months

Title

Objective response, as determined by the investigator

Time Frame

Up to 8 months

Title

Progression-free survival, as determined by the investigator

Time Frame

Up to 18.5 months

Title

Duration of objective response, as determined by the investigator

Time Frame

Up to 14.1 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gordon Bray, M.D.

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)

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