5 research outputs found
Glofitamab, a Novel, Bivalent CD20-Targeting T-CellâEngaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial
Glofitamab; B-Cell Lymphoma; RelapsedGlofitamab; Linfoma de cĂ©lulas B; RecaĂdaGlofitamab; Limfoma de cĂšl·lules B; RecaigudaPURPOSE
Glofitamab is a T-cellâengaging bispecific antibody possessing a novel 2:1 structure with bivalency for CD20 on B cells and monovalency for CD3 on T cells. This phase I study evaluated glofitamab in relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Data for single-agent glofitamab, with obinutuzumab pretreatment (Gpt) to reduce toxicity, are presented.
METHODS
Seven days before the first dose of glofitamab (0.005-30 mg), all patients received 1,000 mg Gpt. Dose-escalation steps were determined using a Bayesian continuous reassessment method with overdose control. Primary end points were safety, pharmacokinetics, and the maximum tolerated dose of glofitamab.
RESULTS
Following initial single-patient cohorts, 171 patients were treated within conventional multipatient cohorts and received at least one dose of glofitamab. This trial included heavily pretreated patients with R/R B-NHL; most were refractory to prior therapy (155; 90.6%) and had received a median of three prior therapies. One hundred and twenty-seven patients (74.3%) had diffuse large B-cell lymphoma, transformed follicular lymphoma, or other aggressive histology, and the remainder had indolent lymphoma subtypes. Five (2.9%) patients withdrew from treatment because of adverse events. Cytokine release syndrome occurred in 86 of 171 (50.3%) patients (grade 3 or 4: 3.5%); two (1.2%) patients experienced grade 3, transient immune effector cellâassociated neurotoxicity syndrome-like symptoms. The overall response rate was 53.8% (complete response [CR], 36.8%) among all doses and 65.7% (CR, 57.1%) in those dosed at the recommended phase II dose. Of 63 patients with CR, 53 (84.1%) have ongoing CR with a maximum of 27.4 months observation.
CONCLUSION
In patients with predominantly refractory, aggressive B-NHL, glofitamab showed favorable activity with frequent and durable CRs and a predictable and manageable safety profile
ICO-ICS Praxis para el tratamiento mĂ©dico y con irradiaciĂłn del mieloma mĂșltiple
Tractament mĂšdic; Tractament amb irradiaciĂł; Mieloma mĂșltipleMedical treatment; Irradiation treatment; Multiple myelomaTratamiento mĂ©dico; Tratamiento con irradiaciĂłn; Mieloma mĂșltipleEl mieloma mĂșltiple (MM) Ă©s una neoplĂ sia de cĂšl·lules plasmĂ tiques que representa al voltant de lâ1% del total de neoplĂ sies i el 10% de les neoplĂ sies hematolĂČgiques. TĂ© una incidĂšncia aproximada de 4-5 nous casos/100.000 habitants/any i presenta una incidĂšncia mĂ xima entre els 70 i 75 anys dâedat. Un 35% dels afectats tĂ© menys de 65 anys. Els objectius d'aquesta guia sĂłn: desenvolupar i difondre la ICO-ICSPraxi per al tractament del mieloma mĂșltiple; disminuir la variabilitat terapĂšutica entre els pacients tractats en els diferents centres dâaquesta instituciĂł; implementar i avaluar els resultats de la terapĂšutica en els pacients amb mieloma mĂșltiple tractats dâacord amb les recomanacions dâaquesta guia
T021: Radiation-Free Therapy as the INitial treatment of Good-prognosis early non-bulky Hodgkin lymphoma, defined by a low Metabolic Tumor Volume and a negative PET-2 - RAFTING Trial.
T098: Brentuximab Vedotin plus ESHAP (BRESHAP) versus ESHAP in Patients with Relapsed or Refractory Classical Hodgkinâs Lymphoma. Interim Results of the BRESELIBET Prospective Clinical Trial.
Brentuximab vedotin and ESHAP is highly effective as second-line therapy for Hodgkin lymphoma patients (long-term results of a trial by the Spanish GELTAMO Group)
Background: In this work, we assessed the efficacy and safety of brentuximab vedotin (BV) plus ESHAP (BRESHAP) as second-line therapy for Relapsed/Refractory Hodgkin lymphoma (RRHL) to improve the results before autologous stem-cell transplantation (ASCT).
Patients and methods: This was a multicenter, open-label, phase IâII trial of patients with RRHL after first-line chemotherapy. Treatment had three 21-day cycles of etoposide, solumedrol, high-dose AraC, and cisplatin. BV was administered at three dose levels (0.9, 1.2, and 1.8âmg/kg) intravenous on day â1 to 3â+â3 cohorts of patients. Final BV dose was 1.8âmg/kg. Responding patients proceeded to ASCT, followed by three BV courses (1.8âmg/kg, every 21âdays). Main end points for evaluation were maximum tolerable dose and overall and complete response (CR) before ASCT.
Results: A total of 66 patients were recruited (median age 36âyears; range 18â66): 40 were primary refractory, 16 early relapse and 10 late relapse. There were 39 severe adverse events were reported in 22 patients, most frequently fever (nâ=â25, 35% neutropenic), including 3 deaths. Grade 3â4 hematological toxicity presented in 28 cases: neutropenia (nâ=â21), thrombocytopenia (nâ=â14), and anemia (nâ=â7). Grade â„3â4 extrahematological adverse events (â„5%) were non-neutropenic fever (nâ=â13) and hypomagnesaemia (nâ=â3). Sixty-four patients underwent stem-cell mobilization; all collected >2Ă10e6/kg CD34+ cells (median 5.75; range 2.12â33.4). Overall response before transplant was 91% (CI 84% to 98%), including 70% (CRs 95% CI 59% to 81%). 60 patients were transplanted with no failure engraftments. Post-transplant response was CR in 49 patients (82% CI 73% to 91%) and partial responses in six (10% CI 5% to 15%). After a mean follow-up of 27âmonths, the 30-month time to treatment to failure was 74% (95% CI 68% to 80%), progression-free survival 71% (95% CI 65% to 77%), and overall survival 91% (CI 84% to 98%).
Conclusion: BRESHAP looks a safe and effective pre-transplant induction regimen, does not jeopardize transplant and allows long-term remissions and survival