BridgeMD
Compares treatment options for Follicular Lymphoma
Official title A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)
ClinicalTrials.gov ID: NCT06911502
What this study is testing
What is Golcadomide?
Golcadomide is an investigational medicine, being studied as a potential treatment for follicular lymphoma.
Also referred to as CC-99282, BMS-986369.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or...
- Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
- Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross...
- Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes...
- Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20...
You likely can't join if
- Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL), including history of...
- Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly...
- Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
- Presence or history of central nervous system (CNS) involvement by lymphoma.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
See the full eligibility criteria
- \- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with...
- Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
- Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.
- Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
- Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg...
- Lab parameters: i) Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L), ii) PLT count ≥ 75,000 cells/mm3 (75 x 109 /L) iii) Hb ≥ 7.5 g/dL
- estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0× ULN.
- Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria). In case of documented liver involvement by lymphoma, serum...
- Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated...
- Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL), including history of prior large B-cell lymphomas (LBCL), or any other indolent lymphoma.
- Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.
- Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
- Presence or history of central nervous system (CNS) involvement by lymphoma.
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
- Participants with a history of progressive multifocal leukoencephalopathy.
- Participant has any other subtype of lymphoma.
- Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
- History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Marietta, Georgia, United States
- Newnan, Georgia, United States
- Arlington Heights, Illinois, United States
- Iowa City, Iowa, United States
- Waukee, Iowa, United States
- Westwood, Kansas, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Towson, Maryland, United States
- Boston, Massachusetts, United States
- Hattiesburg, Mississippi, United States
- Providence, Rhode Island, United States
+ 119 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Little Rock, Arkansas, United States; Duarte, California, United States; San Francisco, California, United States and 133 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.