| Titre |
A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma |
| Protocole ID |
GOLSEEK-2 |
| ClinicalTrials.gov ID |
NCT06425302 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase II |
| Stade |
Lymphome folliculaire/zone marginale |
| Type étude |
Clinique |
| Médicament |
Golcadomide avec rituximab |
| Institution |
CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
 HOPITAL DE CHICOUTIMI
305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
|
| Ville |
Chicoutimi |
| Investigateur(trice) principal(e) |
Dre Vanessa Brunet
|
| Coordonnateur(trice) |
Marie-Claude Tremblay
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- 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:.
- Bulky disease defined as:
- 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).
- Presence of at least one of the following B symptoms:
- Fever (>38°C) of unclear etiology.
- Night sweats.
- Weight loss greater than 10% within the prior 6 months.
- Splenomegaly with inferior margin below the umbilical line.
- Any one of the following cytopenia due to lymphoma:
- Platelets <100,000 cells/mm3 (100 x 109/L).
- Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
- Hemoglobin < 10g/dL (6.25 mmol/L).
- Pleural or peritoneal serous effusion (irrespective of cell content).
- Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).
|
| Critètes d'exclusion |
- 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.
|
Groupe d'étude en oncologie du Québec