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Clinical Trials in Canada / NCT06425302
Active, not recruiting Phase 2

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

NCT06425302 · tracked via the Priya Life Science Canada tracker
Sponsor
Phase
Phase 2
Started
2024-08-30
Last updated
2026-07-31

Condition(s) studied

Lymphoma, Follicular

Investigational drug(s) / intervention(s)

Golcadomide →Rituximab →Cyclophosphamide →Doxorubicin →Vincristine →Prednisone →Bendamustine →

Golcadomide: Specified dose on specified days

Rituximab: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Doxorubicin: Specified dose on specified days

Vincristine: Specified dose on specified days

Prednisone: Specified dose on specified days

Bendamustine: Specified dose on specified days

Study summary

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis. * Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable. * Stage II to IV disease. * Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:. i) Bulky disease defined as:. A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm). ii) Presence of at least one of the following B symptoms:. A. Fever (\>38°C) of unclear etiology. B. Night sweats. C. Weight loss greater than 10% within the prior 6 months. iii) Splenomegaly with inferior margin below the umbilical line. iv) Any one of the following cytopenia due to lymphoma:. A. Platelets \<100,000 cells/mm3 (100 x 109/L). B. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L). C. Hemoglobin \< 10g/dL (6.25 mmol/L). v) Pleural or peritoneal serous effusion (irrespective of cell content). vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal). Exclusion Criteria * Clinical evidence of transformed lymphoma by investigator assessment. * Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification. * Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
Local Institution - 0152 Birmingham Alabama
Local Institution - 0055 Anchorage Alaska
Local Institution - 0180 Phoenix Arizona
Local Institution - 0190 Tucson Arizona
Local Institution - 0035 San Francisco California
Local Institution - 0022 Washington D.C. District of Columbia
Local Institution - 0209 Fort Myers Florida
Local Institution - 0005 Jacksonville Florida
Local Institution - 0210 St. Petersburg Florida
Local Institution - 0026 Tampa Florida
Local Institution - 0208 West Palm Beach Florida
Local Institution - 0019 Westwood Kansas
Local Institution - 0031 Rochester Minnesota
Local Institution - 0111 Henderson Nevada
Local Institution - 0183 Hackensack New Jersey
Local Institution - 0052 Salt Lake City Utah
Local Institution - 0201 Norfolk Virginia
Local Institution - 0202 Seattle Washington
Local Institution - 0046 Liverpool New South Wales
Local Institution - 0070 South Brisbane Queensland
Local Institution - 0181 Traralgon Victoria
Local Institution - 0061 Porto Alegre Rio Grande do Sul
Local Institution - 0060 Rio de Janeiro Brazil
Local Institution - 0058 São Paulo Brazil
Local Institution - 0056 São Paulo Brazil
Local Institution - 0064 Toronto Ontario
Local Institution - 0205 Chicoutimi Quebec
Local Institution - 0049 Santiago Santiago Metropolitan
Local Institution - 0050 Santiago Santiago Metropolitan
Local Institution - 0101 Saint-Cloud Hauts-de-Seine
Local Institution - 0103 Lille Nord
Local Institution - 0121 Poitiers Vienne
Local Institution - 0118 Paris France
Local Institution - 0197 Regensburg Bavaria
Local Institution - 0188 Chemnitz Saxony
Local Institution - 0189 Dresden Germany
Local Institution - 0198 Rome Lazio
Local Institution - 0179 Rozzano Milano
Local Institution - 0076 Bologna Italy
Local Institution - 0075 Naples Italy

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Celgene trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06425302 on ClinicalTrials.gov ↗ ← All trials in Canada