Phase
Condition
Lymphoma, B-cell
Follicular Lymphoma
Lymphoma
Treatment
Biospecimen Collection
Positron Emission Tomography
Rituximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent obtained to participate in the study and Health InsurancePortability and Accountability Act (HIPAA) authorization for release of personalhealth information
Age ≥ 18 years at the time of consent
Diagnosis of B-cell Non-Hodgkin's lymphoma including either large B-cell lymphoma orfollicular lymphoma. Large B-cell subtypes include but are not limited to diffuselarge B-cell lymphoma, high grade B-cell lymphoma (except Burkitt's Lymphoma),primary mediastinal B-cell lymphoma, and diffuse large B cell lymphoma transformedfrom indolent lymphomas
Eastern Cooperative Oncology Group (ECOG) Score = 0-2
Prior receipt of standard of care CD19 directed CAR-T cell therapy includingaxicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel
Pre-CART imaging with PET within 60 days of infusion of CD19.CAR-T. If patient'sreceive bridging therapy, PET evaluation post bridging therapy is encouraged as partof institutional guidelines, but not mandated for inclusion
Evidence of objective response on PET/CT at 30 days post CD19.CAR-T infusion (+15/-5days) compared to baseline pre-CART PET imaging. Objective response in this trial isdefined by reduced fludeoxyglucose F-18 (FDG) uptake or reduction in mass size andincludes mixed response
Evidence of sub-optimal response to CD19.CAR-T as defined in this trial by DeauvilleScore ≥ 3 on PET/CT at 30 days post CART infusion (+15/-5 days)
Absolute neutrophil count ≥ 7.5 x 10^8/L (obtained within 14 days prior toinitiating study treatment)
Hematological lab values should be without the use of growth factors ortransfusion support
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Hemoglobin ≥ 8 x 10^9/L (obtained within 14 days prior to initiating studytreatment)
Hematological lab values should be without the use of growth factors ortransfusion support
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Platelets ≥ 50 x 10^9/L (obtained within 14 days prior to initiating studytreatment)
Hematological lab values should be without the use of growth factors ortransfusion support
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Estimated glomerular filtration rate (eGFR) (based on chronic kidneydisease-epidemiology collaboration [CKD-EPI] * patient's body surface area [BSA] [DuBois method]/1.73m^2) ≥ 45 ml/min (obtained within 14 days prior to initiating studytreatment)
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Bilirubin ≤ 1.5 × upper limit of normal (ULN). Subjects with Gilbert's syndrome maybe enrolled despite a total bilirubin level > 2.0 mg/dL if their conjugatedbilirubin is < 2.0 × ULN) (obtained within 14 days prior to initiating studytreatment)
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Aspartate aminotransferase (AST) ≤ 3.0 × ULN (obtained within 14 days prior toinitiating study treatment)
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Alanine aminotransferase (ALT) ≤ 3.0 × ULN (obtained within 14 days prior toinitiating study treatment)
Note: Changes in laboratory parameters during the study should not beconsidered adverse events unless they meet criteria for dose modification(s) ofstudy medication outlined by the protocol and/or worsen from baseline duringtherapy
Patients must be able to provide adequate tissue samples for minimal residualdisease (MRD) analysis for identification (ID) of baseline tumor deoxyribonucleicacid (DNA). 2 forms of tissue will be acceptable: optional baseline biopsy tissuepost CART and prior to initiation of CC-99282, or archival tumor tissue (ex.formalin-fixed paraffin embedded [FFPE] tumor blocks) from a biopsy containinglymphoma prior to CD19.CART
Fridericia's formula-corrected QT interval (QTcF) < 470 ms
Patients must be able to swallow/absorb capsules
Females of childbearing potential must have a negative serum pregnancy test within 3days prior to enrollment. Pregnancy tests must be medically supervised with aminimum sensitivity of 25mIU/ml. NOTE: a female of childbearing potential is afemale who: 1) has achieved menarche at some point, 2) has not undergone ahysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) forat least 24 consecutive months, i.e. has had menses at any time in the preceding 24consecutive months. Documentation of postmenopausal status must be provided. Furtherinformation on pregnancy testing and the definition of a female of childbearingpotential located in the CC-99282 pregnancy prevention plan document
Females of childbearing potential are required to use 2 forms of effective methodsof contraception or to agree to practice complete abstinence from the time ofinformed consent, without interruption, at least 28 days before starting CC-99282,throughout the entire duration of CC-99282, during dose interruptions and for atleast 6 months and 2 weeks after the last dose of golcadomide (BMS-986369)/CC-99282.The two contraception methods can be comprised one highly effective method and oneadditional effective (barrier) method. Further information on acceptable methods islocated in the CC-99282 pregnancy prevention plan document
Male subjects with female partners must practice complete abstinence or agree to usea condom during sexual contact with a pregnant female or a female of child bearingpotential while taking CC-99282, during dose interruptions and for at least 3 monthsand 2 weeks following the last dose of CC-99282, even if he has undergone asuccessful vasectomy. Additional information regarding prevention of pregnancy as itpertains to male subjects is contained within the CC-99282 pregnancy prevention plandocument
Subjects with prior or concurrent malignancy whose natural history or treatment doesnot have the potential to interfere with the safety or efficacy assessment of theexperimental regimen are eligible for the trial
Subject is willing and able to comply with study procedures based on the judgementof the investigator or protocol designee
Exclusion
Exclusion Criteria:
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use whilethe mother is being treated on study and lactating females must agree to notbreastfeed while taking study drugs)
Uncontrolled concomitant illness including, but not limited to, symptomaticcongestive heart failure (New York Heart Association [NYHA] class III or IV),unstable angina pectoris, myocardial infarction within 1 month prior to enrollment,uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non compensatedhypertension (Systolic blood pressure >= 180mmHg or diastolic blood pressure >= 120mmHg)
Receipt of CD19.CAR-T for any indication other than that stated within theinclusions criteria
Concomitant use of strong CYP3A inhibitors and inducers. Examples include (but arenot limited to):
CYP3A inhibitors: atazanavir, clarithromycin, indinavir, itraconazole,ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin.
CYP3A inducers: carbamazepine, phenytoin, and rifampin. Patients that are ableto come off moderate CYP3A inhibitors/inducers will require a washout period ofat least 14 days or 5 half-lives, whichever is shorter, prior to the initiationof study treatment
Patients who are actively receiving or have received other investigational agents,including herbal supplements, within 2 weeks or 5 half-lives of enrollment
Study Design
Study Description
Connect with a study center
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.