Informations générales (source: ClinicalTrials.gov)
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 (GOLSEEK-2)
Interventional
Phase 2
Celgene (Voir sur ClinicalTrials)
août 2024
novembre 2028
09 janvier 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | 09/01/2025 11:32:20 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Claude Huriez - CHU de Lille - 59000 - Lille - Nord - France | Franck Morschhauser, Site 0103 | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - 75010 - Paris - France | Catherine Thieblemont, Site 0118 | Contact (sur clinicalTrials) | |||
| Local Institution - 0121 - 86021 - Poitiers - Vienne - France | Site 0121 | Contact (sur clinicalTrials) | |||
Critères
Tous
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) < 1,500 cells/mm3 (1.5 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.
- 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) < 1,500 cells/mm3 (1.5 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.