BridgeMD
A phase 2 study of the effectiveness of golcadomide (CC-99282) for patients with large B-cell lymphoma in the brain
EU CTIS ID: 2024-517051-12-00
What this study is testing
The primary objective of the study is a best observed ORR (complete remission and partial remission) of 40%, according to the IPCG response criteria among patients with R/R PCNSL and according to IPCG and Lugano criteria among patients with sCNSL
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 18 years as minimum age
- Additional inclusion criteria cohort A: Patients must have received prior high-dose methotrexate based chemotherapy.
- Additional inclusion criteria cohort B: Diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO 2022 classification: Follicular lymphoma (FL) grade 3B or transformed FL, DLBCL and HGBCL with MYC and BCL2 rearrangements
- Additional inclusion criteria cohort B: Progression or relapse with CNS localization with or without systemic relapse
- Additional inclusion criteria cohort B: 3 Diagnosis of CNS localization at inclusion based on at least one of the following: Unequivocal morphological and/or immunophenotypically evidence of Cerebrospinal Fluid (CSF) lymphoma, clinical AND Magnetic resonance imaging (MRI) evidence of leptomeningeal localization, brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma, concurrently with systemic progression or recurrence and biopsy-proven brain parenchymal NHL localization of previously diagnosed systemic NHL
- WHO-performancestatus ≤ 2
You likely can't join if
- The following DLBCL subtypes are not allowed: a) Patients with intravitreal lymphoma, b) Primary testicular lymphoma, c) Intravascular lymphoma, d) Epstein-barrvirus (EBV) driven lymphoma, e) Post-transplant LPDs
- Significant renal dysfunction (estimated creatinine clearance < 45 ml/min after rehydration according to local practice)
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
- Active or uncontrolled viral infection (Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Coronavirus disease (COVID))
- Hypersensitivity to the active substance.
- Patients unable to swallow capsules or with diseases significantly affecting the gastrointestinal function.
See the full eligibility criteria
Who can join
- ≥ 18 years as minimum age
- Additional inclusion criteria cohort A: Patients must have received prior high-dose methotrexate based chemotherapy.
- Additional inclusion criteria cohort B: Diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO 2022 classification: Follicular lymphoma (FL) grade 3B or transformed FL, DLBCL and HGBCL with MYC and BCL2 rearrangements
- Additional inclusion criteria cohort B: Progression or relapse with CNS localization with or without systemic relapse
- Additional inclusion criteria cohort B: 3 Diagnosis of CNS localization at inclusion based on at least one of the following: Unequivocal morphological and/or immunophenotypically evidence of Cerebrospinal Fluid (CSF) lymphoma, clinical AND Magnetic resonance imaging (MRI) evidence of leptomeningeal localization, brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma, concurrently with systemic progression or recurrence and biopsy-proven brain parenchymal NHL localization of previously diagnosed systemic NHL
- WHO-performancestatus ≤ 2
- Patient must understand and voluntarily sign an Informed Concent Form (ICF) prior to any study related assessments/procedures being conducted
- Patient is willing and able to adhere to the study visit schedule and other protocol requirements
- Haemoglobin > 5 mmol/l
- Absolute neutrophil count (ANC) >1.0x10^9/l without growth factor support for 7 days
- Platelet count >75x10^9/l without transfusions for 7 days
- Patient agrees not to participate in any other interventional study while on protocol treatment without approval of the Principal Investigator
- Additional inclusion criteria cohort A: Additional inclusion criteria cohort A 1 Diagnosis of a R/R PCNSL according to the WHO 2022 classification
What rules you out
- The following DLBCL subtypes are not allowed: a) Patients with intravitreal lymphoma, b) Primary testicular lymphoma, c) Intravascular lymphoma, d) Epstein-barrvirus (EBV) driven lymphoma, e) Post-transplant LPDs
- Significant renal dysfunction (estimated creatinine clearance < 45 ml/min after rehydration according to local practice)
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
- Active or uncontrolled viral infection (Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Coronavirus disease (COVID))
- Hypersensitivity to the active substance.
- Patients unable to swallow capsules or with diseases significantly affecting the gastrointestinal function.
- History of active malignancy (other than lymphoma) requiring ongoing treatment during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- Patient is pregnant, breast-feeding patients, or intending to become pregnant during participation in the study
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patient has received prior therapy with CRBN-modulating drug (eg, lenalidomide, avadomide/CC-122, pomalidomide, golcadomide (CC-99282)) within 5 half-lives or 4 weeks, whichever is shorter, prior to starting investigational product.
- Severe cardiovascular disease (arrhythmias not well controlled with medication, congestive heart failure or symptomatic ischemic heart disease)
- Severe pulmonary dysfunction
- Severe neurological or psychiatric disease
- Significant hepatic dysfunction (serum transaminases ≥ 3 times upper limit of normal or bilirubin ≥ 3 x ULN (unless bilirubin rise is due to Gilbert's syndrome))
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.