Safety of Interferon Gamma-1b With Rituximab in Non-Hodgk... | NCT00057447

Studies
Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

NCT00057447

Sponsor

InterMune

Status

Terminated

Last Update Posted

Nov 1, 2007Estimated

Enrollment

24Actual

Phase

Phase 1Phase 2

Conditions

Non-Hodgkin's Lymphoma

Interventions

Interferon Gamma-1b
Rituximab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

administrative reasons

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Jun 2004Actual

First Submitted Date

Apr 1, 2003

First Submission Date that Met QC Criteria

Apr 2, 2003

First Posted Date

Apr 3, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2007

Last Update Posted Date

Nov 1, 2007Estimated

Description Module

Brief Summary

Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)

International study with sites in the Czech Republic and Poland

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon Gamma-1b	Drug	100 or 200 mcg, SQ, 3x per week
Rituximab	Drug	375 mg per square meters, IV, 1x per week

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)		6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab therapy
Patients who were on other therapy including CHOP or radiation
Previous therapy must have concluded 30 days prior to enrollment
Demonstrable CD20-positive tumor population in lymph nodes or bone marrow

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Williamson Bradford, MD	InterMune	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intermune Inc		Brisbane	California	94005	United States

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C554125	interferon gamma-1b
D000069283	Rituximab

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided