Myocet (non-pegylated liposomal doxorubicin)

P3, N=448, Recruiting, Mural Oncology, Inc | Active, not recruiting --> Recruiting | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2025 --> May 2026

First line metronomic chemotherapy for HER2 negative ABC had similar clinical activity and quite better tolerability than standard schedule and could be considered a further treatment option when chemotherapy is indicated.

P1, N=40, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P3, N=376, Active, not recruiting, Mural Oncology, Inc | Recruiting --> Active, not recruiting

P2, N=149, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Dec 2023 --> Jan 2023

P1, N=36, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting | Initiation date: May 2023 --> Feb 2024

P2, N=164, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Dec 2023

P2, N=149, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Nov 2024

The pharmacological costs were calculated following treatment protocol of GeparSixto where TNBC patients received neoadjuvant paclitaxel plus Myocet®-nonpegylated liposomal doxorubicin (PM) or PM plus carboplatin (PMCb), both arms including bevacizumab. The most efficient scenarios are the functional RAD51 test and all comers. Both tBRCA1/2 and genomic HRD by Myriad Mychoice® scenarios provide worse health outcomes at a higher cost, based on the data of the GeparSixto trial. This study highlights the potential overall benefit of functional HRD biomarkers to predict PARPi sensitivity.

P2/3, N=260, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2023 --> Oct 2024

P3, N=579, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Aug 2024

The combination including NPL-DOX in elderly patients revealed low rate of cardiac toxic effects. Comparative trials are encouraged.

P2/3, N=443, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jun 2024 --> May 2023

Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the most commonly used regimen for the upfront treatment of diffuse large B-cell lymphoma (DLBCL)...Substituting doxorubicin with non-PEGylated liposomal doxorubicin (R-COMP) may reduce the risk of cardiac events, but its efficacy has never been demonstrated in prospective trials...Our study suggests that R-COMP represents a potentially curative treatment for EPI intermediate-/high-risk older patients, even in the presence of a baseline cardiopathy. R-CHOP is confirmed as the standard therapy for patients at low risk.

P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=96 --> 0 | Trial completion date: Jul 2024 --> Mar 2023 | Suspended --> Withdrawn | Trial primary completion date: Jul 2024 --> Mar 2023

P2/3, N=444, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024

P2/3, N=562, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024

P1, N=36, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

P1, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026

P1, N=36, Recruiting, National Cancer Institute (NCI) | N=66 --> 36

P1, N=66, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> May 2025 | Trial primary completion date: Apr 2023 --> May 2025

P2, N=13, Completed, Mayo Clinic | Recruiting --> Completed | N=240 --> 13

P2, N=164, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting

P3, N=80, Active, not recruiting, West German Study Group | Unknown status --> Active, not recruiting | Trial completion date: Oct 2020 --> Oct 2024

P2, N=96, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

Gemtuzumab ozogamicin (GO) is an anti-CD33 monoclonal antibody approved by EMA in 2018 for the treatment of patients aged 15 years and above with previously untreated de novo CD33-positive AML, in combination with daunorubicin and cytarabine...Two additional cycles (Clofarabin-daunorubicin-Cytarabin and high dose Etoposide) were administered, without response. The patient then received additional treatment based on the association of GO, Doxorubicin, Aracytin and Midostaurin. Haploidentical HSCT with peripheral TCRalpha/beta-CD19 depleted cells from father was then performed in aplasia, preceded by a myeloablative conditioning regimen based on TBI-Melphalan...Additional treatment with Fludarabin-Aracytin-Myocet-G CSF could not prevent disease progression... GO integration into the FLT3-AML therapy before HSCT resulted in improved outcomes for pediatric patients with refractory AML. Combination of targeted inhibition of FLT3 and CD33 followed by allogeneic HSCT could be a promising therapeutic opportunity for refractory/relapsed pediatric AML.

P2, N=164, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

P2, N=29, Completed, University of Wisconsin, Madison | Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Feb 2022

P1, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

P3, N=579, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2022 --> Dec 2023

P2, N=96, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2022 --> Jul 2024 | Trial primary completion date: Sep 2022 --> Jul 2024

P2, N=96, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting

P1, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022

Investigators chose between 3 CT regimens: 4 cycles of doxorubicin/cyclophosphamide, non-pegylated liposomal doxorubicin/cyclophosphamide or docetaxel/cyclophosphamide, given q3w with G-CSF. Standard ET consisted of 5 years of aromatase inhibitor, tamoxifen or a sequence based on tolerance... In this large phase III trial, we did not find a statistically significant OS benefit with the addition of CT to ET after surgery for ER+ HER2- BC with a high GGI. Analysis of the other outcome measures will be presented.

Hematologic toxicity with neutropenia was the most frequent adverse event, but the treatment was well tolerated maintained a manageable cardiotoxicity. Non-pegylated liposomal doxorubicin may represent a valid therapeutic option in first-line for elderly patients with HER/2 negative MBC improving survival, anti-tumor response rate and de-creases cardiotoxicity.

P2/3, N=562, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

While there was no difference in survival for the entire cohort, the HR+/HER2-subgroup significantly benefits from iddEPC. This supports the concept of an additional effect of NACT beyond pCR in patients with HR+/HER2- BC. CLINICALTRIALS.

The regimen consisted of R 375 mg/sqm and NPLD 50 mg/sqm administered intravenously on cycle day 1, plus prednisone 50 mg orally on days 1 to 5, every 21 days for 6 courses. Our results confirm that, in patients 80 years or older with DLBCL, R-NPDL is very effective and safe combination. Among prognostic factors, only the elevated LDH (> 1.25 upper limit) strongly correlates with overall survival and risk of relapse, in univariate (p=0.001, p=0.003) and multivariate (p=0.002, p=0.005) analysis, respectively. In patients who achieved EFS18 the probability to survive 24 and 36 months is of 90.5 and 67.9%, respectively.

The RAD51 test identifies tumors with functional HRD and is highly concordant with tBRCA mutation and genomic HRD. RAD51 independently predicts clinical benefit from adding Cb to NACT in TNBC. Our results support further development to incorporate RAD51 testing in clinical decision-making.

P2/3, N=444, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

Following three pivotal first-line phase III trials in HER2-negative metastatic BC (MBC), this drug was finally approved in combination with cyclophosphamide in this specific setting. Given the increasing complexity of the therapeutic scenario of HER2-negative MBC, we have carefully revised the most updated literature on the topic and dissected the potential role of NPLD in the evolving therapeutic algorithms.

Our results confirm that, in patients 80 years or older with DLBCL, R-NPDL is very effective and safe combination. Among prognostic factors, only the elevated LDH (≥1.25 upper limit) strongly correlates with overall survival and risk of relapse, in univariate (p = 0.001, p = 0.003) and multivariate (p = 0.002, p = 0.005) analysis, respectively. In patients who achieved EFS18 the probability to survive 24 and 36 months is of 90.5 and 67.9%, respectively.