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Active (not recruiting) Phase 2 NCT06425302

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

Phase 2 – studying effectiveness and dosage
Conditions: Lymphoma, Follicular

Sponsor: Celgene

trial.available_in: БГ
Overview
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).
Who can participate
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.
Locations 13
Australia (1)
Local Institution - 0046
Liverpool , New South Wales
Brazil (1)
Local Institution - 0061
Porto Alegre , Rio Grande do Sul
Canada (1)
Local Institution - 0064
Toronto , Ontario
Chile (1)
Local Institution - 0049
Santiago , Santiago Metropolitan
France (1)
Local Institution - 0101
Saint-Cloud , Hauts-de-Seine
Germany (1)
Local Institution - 0197
Regensburg , Bavaria
Italy (1)
Local Institution - 0198
Rome , Lazio
Poland (1)
Local Institution - 0187
Skórzewo , Greater Poland Voivodeship
South Korea (1)
Local Institution - 0100
Busan , Pusan-Kwangyǒkshi
Spain (1)
Local Institution - 0196
Palma , Balears [Baleares]
Taiwan (1)
Local Institution - 0094
Kaohsiung City
United Kingdom (1)
Local Institution - 0175
Southampton , Hampshire
United States (1)
Local Institution - 0152
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.08.2024
Completion date
27.11.2028
Registry ID
NCT06425302
Source
anzctr
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