Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma

Lymphoma, Follicular Clinical Trial

— PREMIER  

Official title:

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

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

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular

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