Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Study connect Webseite durchsuchen

Recruiting

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma - CA073-1022

Aktualisiert: 16 November, 2024   |   ClinicalTrials.gov

Celgene ist eine reine Tochtergesellschaft von Bristol-Myers Squibb

Zusammenfassung zum Ausdrucken

SIND SIE AN DIESER STUDIE INTERESSIERT?
Drucken Sie diese Seite und den Leitfaden zu klinischen Studien aus, damit Sie sie mit Ihrem Arzt besprechen können.
Nutzen Sie unseren Leitfaden zu klinischen Studien, um mehr über die Schritte für die Teilnahme zu erfahren. Informieren Sie sich über die wichtigsten Punkte, über die Sie nachdenken sollten, und die Fragen, die Sie dem Studienteam stellen sollten, bevor Sie sich für eine Teilnahme entscheiden.

Studiendetails

  • Phase 2

    Phase

  • Geschlecht(er)

  • 18+

    Altersgruppe

  • 45

    Standort(e)

  • Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: Golcadomide Dose 1 + Rituximab
Drug: Golcadomide, Rituximab
Experimental: Golcadomide Dose 2 + Rituximab
Drug: Golcadomide, Rituximab
Experimental: Rituximab + Chemotherapy
Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Bendamustine

Wichtigste Eignungskriterien

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.

Wir empfehlen Ihnen dringend, sich an Bristol Myers Squibb zu wenden, um Nebenwirkungen (unerwünschte Ereignisse) zu melden.
Nebenwirkungen (unerwünschte Ereignisse) und andere meldepflichtige Ereignisse werden hier definiert
Nebenwirkungen (unerwünschte Ereignisse) oder Produktqualitätsbeschwerden melden: Medizinische Information