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Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Follicular

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Trial Information

Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma


On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of
29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This
study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer
HealthCare, Inc.

The study was terminated early due to low enrollment; significant changes to the protocol
would have been required to keep pace with the changing therapeutic landscape of indolent
lymphoma.

Inclusion Criteria


Inclusion Criteria (abbreviated list):

- Relapsed follicular B-cell lymphoma

- One or more previous therapies for non-Hodgkin's

- At least one measurable tumor by CT scan or MRI

- Additional criteria to be determined at screening visit

Exclusion Criteria (abbreviated list):

- Rituximab refractory (less than 6 months from last treatment with rituximab to
relapse)

- Currently receiving treatment for another cancer

- Infection currently being treated

- Active Hepatitis B

- History of HIV infection

- Pregnant

- Additional criteria to be determined at screening visit

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12

Outcome Description:

Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.

Outcome Time Frame:

Week 8 (confirmed at Week 12)

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

310421

NCT ID:

NCT00308087

Start Date:

May 2006

Completion Date:

June 2009

Related Keywords:

  • Lymphoma, Follicular
  • Sargramostim
  • Leukine
  • NHL
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Indianapolis, Indiana