💬In plain words
What the trial is, and whether it could suit you
This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some ty
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age ≥ 18 years
* Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with relapsed, progressive and/or refractory disease (Cheson et al. 2014) following treatment with one or two prior lines of standard therapy, no more than two lines of therapy are permitted:
* Diffuse large B-cell lymphoma not otherwise specified (NOS) including:
* Transformed lymphoma
* Germinal center B-cell type
* Activated B-cell type
* High-grade B-cell lymphoma (HGBCL), NOS
* High grade B-cell lymphoma with MYC and BCL2 translocation
* Primary mediastinal (thymic) large B-cell lymphoma
* Grade 3B follicular lymphoma
* T-cell/histiocyte-rich large B-cell lymphoma
* Large B-cell lymphoma with IRF4 rearrangement
* Primary cutaneous diffuse large B-cell lymphoma (DLBCL), leg type
* Epstein-Barr virus (EBV) positive DLBCL, NOS
* DLBCL associated with chronic inflammation
* Intravascular large B-cell lymphoma
* ALK positive large B-cell lymphoma
* NOTE: Richters transformation patients are excluded
* Measurable disease by PET-CT with at least one lymph node or other type of lesion that has a size \> 1.5 cm in the transverse diameter, as defined by Lugano classification
* NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
* Patient is potentially eligible for CAR-T therapy as determined by treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Hemoglobin \> 7.0 g/dL (obtained ≤ 14 days prior to registration)
* Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to registration); growth factor support allowed at physician discretion
* Platelet count ≥ 75,000/mcL (obtained ≤ 14 days prior to registration)
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration); if total bilirubin is \> 1.5 ULN, direct bilirubin must be normal
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if there is evidence of parenchymal liver involvement with lymphoma) (obtained ≤ 14 days prior to registration)
* Estimated Glomerular function (eGFR) of \>= 30 mL/min/1.73m\^2 using the Cockcroft-Gaultmodification of diet in renal disease (MDRD) formula or Chronic Kidney Disease - Epidemiology Collaboration formula (CKD-EPI). CKD-EPI can be calculated either using creatinine or cystatin C. The same eGFR cutoff applies in case of documented renal involvement by lymphoma (obtained ≤ 14 days prior to registration)
* Have 2 negative pregnancy tests as verified by the investigator prior to starting CC-99282:
* A negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at screening (between 10 to 14 days prior to cycle 1 day 1)
* A negative serum or urine pregnancy test (investigator's discretion) within 24 hours prior to cycle 1 day 1 of study treatment
* Provide written informed consent
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Subjects must agree not to donate blood while receiving golcadomide, during dose interruptions and for ≥ 28 days following the last dose of golcadomide
Exclusion Criteria:
* Any of the following because this study involves an investigational agent that has known genotoxic, mutagenic, and teratogenic effects:
* Pregnant persons
* Nursing persons
* Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
* Persons of childbearing potential (PCBP) unwilling to use two reliable forms of contraception simultaneously or to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[e.g., calendar, ovulation, symptothermal or postovulation methods\] and withdrawal are not acceptable methods of contraception) from heterosexual contact during the following time periods related to this study:
* For ≥ 28 days before starting treatment, during treatment and dose interruptions, and for ≥ 28 days after the last dose of golcadomide
* Examples of highly effective methods of contraception:
* Intrauterine device (IUD)
* Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory
* Progesterone-only pills \[e.g., desogestrel\])
* Tubal ligation
* Partner's vasectomy
* Examples of additional effective methods:
* Male condom
* Diaphragm
* Cervical cap
* Persons who can father a child unwilling to practice complete abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[e.g., calendar, ovulation, symptothermal or post-ovulation methods\] and withdrawal are not acceptable methods of contraception.) or unwilling to use a condom during sexual contact with a pregnant person or a PCBP during treatment and dose interruptions, and for \> 28 days following the last dose of golcadomide, even if they have undergone a successful vasectomy
* Persons who can father a child and are unwilling to refrain from donating semen or sperm while receiving golcadomide, during dose interruptions, or for ≥ 28 days following the last dose of golcadomide
* Life expectancy \< 3 months
* Any of the following prior therapies:
* Any prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to registration
* Any prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to registration, whichever is shorter
* Exception: Monoclonal and bispecific antibodies is acceptable
* Prior therapy with golcadomide ≤ 4 we