NCT00177554

Brief Summary

The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

3.5 years

First QC Date

September 13, 2005

Last Update Submit

May 27, 2008

Conditions

Non-Hodgkin Lymphoma

Keywords

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    May 2007,May 2008, May2009, May 2010

Secondary Outcomes (4)

  • PET-CT conversion rate

    May2007

  • Frequency and severity of adverse events

    May 2007

  • Duration of complete response

    May 2007,May 2008, May 2009, May 2010

  • Time to next lymphoma therapy

    May 2207,May2008,May2009, May2010

Interventions

Chemotherapy and RadioimmunotherapyDRUG

CHOP-R x 3 cycles followed by zevalin and extended rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
  • No prior chemotherapy
  • No prior monoclonal antibody therapy
  • Bulky or symptomatic disease, stage II-IV
  • Performance status 0-2

You may not qualify if:

  • Impaired bone marrow reserve
  • Presence of CNS lymphoma
  • Serious nonmalignant disease or active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

  • Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.

    PMID: 18981007DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Drug TherapyRadioimmunotherapy

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsImmunotherapyImmunomodulationBiological TherapyCombined Modality TherapyRadiotherapy

Study Officials

  • Samuel A Jacobs, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

November 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

US(1)