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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00308087
Other study ID # 310421
Secondary ID 91499PREMIER
Status Terminated
Phase Phase 2
First received March 28, 2006
Last updated December 2, 2013
Start date May 2006
Est. completion date June 2009

Study information

Verified date December 2013
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 75
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Sargramostim (Leukine)
Sargramostim 250 µg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
Rituximab
Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12 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. Week 8 (confirmed at Week 12) No
Secondary Summary of Treatment-Emergent Adverse Events (TEAE) Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication. up to 12 weeks Yes
Secondary Participant Summary of Best Response Across All Visits Count of participants' best response within categories defined by the International Working Group (IWG):
> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),
> Complete Response Unconfirmed (unconfirmed complete disappearance),
> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),
> Stable Disease (neither response nor disease progression),
> Progression (new lesion or increase by 50% of previously involved sites from nadir).
up to 24 months No
Secondary Kaplan-Meier Estimates of Progression-Free Survival Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death. 24 months No
Secondary Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death. 24 months No
Secondary Summary of Cost Effectiveness A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared. 24 months No
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