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A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-073-14
Enrollment
10
Registered
2015-05-12
Start date
2015-04-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

This is a double blind, randomized, phase 3 clinical trial, (to see complete information go to dossier)

Sponsors

PFIZER S.A.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Male or female patients aged 18 years or older. 2.Histologically confirmed, Grade 1-3a, untreated, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma). NOTE: Patients can be entered based on a diagnosis of CD20+ follicular lymphoma confirmed at the investigational site. Archival tissue must be sent to the central pathology reviewer for confirmation of diagnosis. Patients must have tissue available for the central pathology review to be enrolled. (see dossier to see information complete)

Exclusion criteria

Exclusion criteria: 1. Patients who are not candidates for rituximab monoterapy (see dossier for complete information)

Countries

Andorra, Brazil, Croatia, Germany, Greece, India, Italy, Japan, Korea South, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States

Contacts

Public Contactsara flores

PFIZER S.A.

sara.flores@pfizer.com6152004

Outcome results

None listed

Source: REPEC (via WHO ICTRP)