- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Enrollment closed, Trial primary completion date: Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL (clinicaltrials.gov) - Feb 24, 2023 P1, N=10, Active, not recruiting, Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Sep 2022 --> Sep 2023 Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Jul 2023
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment closed, Combination therapy, Checkpoint inhibition, IO biomarker: NCI-2016-01300: Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia (clinicaltrials.gov) - Feb 24, 2023 P1, N=30, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Jul 2023 Suspended --> Active, not recruiting
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / Ono Pharma, BMS, Imbruvica (ibrutinib) / AbbVie, J&J
Trial termination: Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation (clinicaltrials.gov) - Feb 17, 2023 P2, N=9, Terminated, Suspended --> Active, not recruiting Completed --> Terminated; The study was closed for slow accrual
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
MIXED DONOR CHIMERISM IN PAEDIATRIC B-ALL PATIENTS BRIDGED TO TRANSPLANT WITH BLINATUMOMAB (ePoster Area) - Feb 11, 2023 - Abstract #EBMT2023EBMT_1653; It is likely this MDC reflects reduced pre-transplant treatment intensity as the current UK Relapse Guidelines combines Blinatumomab with less intensive reinduction chemotherapy than IntReALL or COG protocols. Increased MDC in the Blinatumomab group is not yet associated with higher relapse rates, although the follow-up in the Blinatumomab arm is short.
- |||||||||| Tecartus (brexucabtagene autoleucel) / Gilead
BREXUCABTAGENE AUTOLEUCEL FOR ADULT PATIENTS WITH REFRACTORY/RELAPSED ACUTE LYMPHOBLASTIC LEUKEMIA: COST-EFFECTIVENESS IN THE CLINICAL SUBSETS (ePoster Area) - Feb 11, 2023 - Abstract #EBMT2023EBMT_1210; Expected overall survival (OS) is particularly poor (i.e. less than 12 months) in patients relapsing or not responding after/to frontline therapy (R/R) despite being offered standard of care (SOC) with targeted agents (Blinatumomab (BLIN), Inotuzumab Ozogamicin (INO)) or chemotherapy (CIT), +/- tyrosin-kinase inhibitors (TKI), possibly followed by allogeneic stem cell-transplantation (aSCT). Brexucabtagene autoleucel is a cost-effective alternative to SOC for adult patients with R/R LLA, both Ph+ and Ph-.
- |||||||||| Tecartus (brexucabtagene autoleucel) / Gilead
SUBGROUP ANALYSES OF BREXUCABTAGENE AUTOLEUCEL (BREXU-CEL), AN ANTI-CD19 CAR T-CELL THERAPY, IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) IN ZUMA-3 (ePoster Area) - Feb 11, 2023 - Abstract #EBMT2023EBMT_1195; P1/2 Adults with R/R B-ALL benefitted from brexu-cel, with manageable safety, regardless of prior exposure to blinatumomab or prior alloSCT, though survival appeared better in patients without these prior therapies and in earlier lines of therapy, with limited patient numbers in some subgroups.Table. SubgroupNCR/CRi Rate (95% CI)Median DOR (95% CI)Median OS (95% CI)Lines of prior therapy11587%(60-98)4.9 months(1.8-NE)NR(7.6-NE)?26370%(57-81)20.0 months(10.3-NE)25.4 months(15.9-NE)Prior blinatumomabYes3863%(46-78)14.6 months(9.6-NE)15.9 months(8.3-25.4)No4083%(67-93)18.6 months(5.2-NE)47.0 months(18.6-NE)Prior SCTYes2976%(56-90)14.6 months(8.7-23.6)25.4 months(14.2-NE)No4971%(57-83)NR(5.2-NE)47.0 months(10.9-NE)
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: Treatment de-escalation in Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia: the emerging role of chemotherapy-free regimens. (Pubmed Central) - Feb 10, 2023 In particular, encouraging early results have been seen with the combination of blinatumomab plus ponatinib, suggesting that this regimen may represent a chemotherapy-free and SCT-sparing strategy for patients with Ph-positive ALL. Herein, we discuss the current evidence for frontline therapies of Ph-positive ALL, the treatment de-escalation strategies over time, and the role of allogeneic SCT in view of the emergence of newer chemotherapy-free regimens using potent TKIs.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Need for pneumococcal revaccination after blinatumomab therapy: A case report. (Pubmed Central) - Feb 3, 2023 Herein, we discuss the current evidence for frontline therapies of Ph-positive ALL, the treatment de-escalation strategies over time, and the role of allogeneic SCT in view of the emergence of newer chemotherapy-free regimens using potent TKIs. No abstract available
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Feb 3, 2023 P2, N=20, Recruiting, Therefore, further prospective randomized clinical studies should be conducted to improve the long-term efficacy of immunotherapy. Trial completion date: Jan 2023 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Sep 2023
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Clinical, Review, Journal: PEDIATRIC ACUTE LYMPHOBLASTIC LEUKEMIA (Pubmed Central) - Jan 31, 2023 These modalities have demonstrated improved remission rates with reduced toxicity compared to chemotherapy. The role of immunotherapy in the treatment of newly-diagnosed and relapsed patients will be more precisely defined in the near future.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: Infectious complications during monoclonal antibodies treatments and cell therapies in Acute Lymphoblastic Leukemia. (Pubmed Central) - Jan 31, 2023 On the other hand, the infection scenario in the CAR-T setting is quite peculiar: In these patients, infections are more frequent in the first month after infusion and are predominantly bacterial. As the time moves away from day zero, viral infections become more frequent, occurring mainly in patients who have had prolonged cytopenia and major cytokine release syndrome.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
A Case of Multiply Relapsed B-ALL (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_130; Survives a septic shock admission and receives Vinc/Dex x 3 before Blinatumomab...She receives Inotuzumab, Prednisone & frequent IT therapy...She then receives 3 cycles Temozolamide and then is diagnosed with methotrexate-related intracerebral toxicity...Hickman line placement pre-CAR T leads to arterial puncture with massive neck hematoma, requiring prophylactic ventilation and ICU stay. She receives her CAR T cell therapy relatively uneventfully, with Gr I CRS and no evidence of ICANS, and is in morphological remission 1 month post CAR T. She obtains her degree in early childhood development in April 2022 and remains in remission till this day.
- |||||||||| Real Life CAR-T for ALL Adult Patients (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_116;
In our series of 10 infused heavily pretreated adult B-ALL patients, brexu-cel was effective and well tolerated.The incidence of CRS, ICANS, and other toxicities was very low. ORR at day+30 after infusion is very promising, despite a longer follow-up and further study are necessary to confirm these data.
- |||||||||| TP53 Mutations: Impact in Childhood Outcomes after CD19-CAR T-cell Therapy (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_95;
In our series, all patients were refractory or had CD19 negative relapses, most of them before 6 months after CAR-T. The role of early consolidation with HSCT in patients achieving complete remission after CAR-T should be explored.
- |||||||||| Donor-derived CAR-T Cells Co-infusion with T-depleted HSCT (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_55;
P1/2 Allogeneic haploidentical donor-derived CAR-T cells can be safely co-infused with the αβ-T cell-depleted grafts, with minimal CAR-T-related toxicity, without compromise of engraftment and GVHD control. CAR-T cells expand and persist as expected.
- |||||||||| Tecartus (brexucabtagene autoleucel) / Gilead
Cost-effectiveness of Brexucabtagene for Refractory/Relapsed Acute Lymphoblastic Leukemia (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_35; Expected overall survival (OS) is particularly poor (i.e. less than 12 months) in patients relapsing or not responding after/to frontline therapy (R/R) despite being offered standard of care (SOC) with targeted agents (Blinatumomab (BLIN), Inotuzumab Ozogamicin (INO)) or chemotherapy (CIT), +/- tyrosin-kinase inhibitors (TKI), possibly followed by allogeneic stem cell-transplantation (aSCT). Brexucabtagene autoleucel is a cost-effective alternative to SOC for adult patients with R/R LLA, both Ph+ and Ph-.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal: Post-Hematopoietic Cell Transplantation Relapsed Acute Lymphoblastic Leukemia: Current Challenges and Future Directions. (Pubmed Central) - Jan 24, 2023 This review provides insight into use of cellular therapy in MRD positivity and decreasing donor chimerism. It also discusses various modalities of combining cellular therapy with novel agents and discussing the impact of chimeric antigen receptor T-cell therapy in the setting of post allo-HCT relapse both as consolidative therapy and as a bridge to second transplant.
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