Depocyte (liposomal cytarabine) / Mundipharma, Leadiant Biosci - LARVOL DELTA

Treatment strategies for patients with leptomeningeal metastatic disease (LMD): a network meta-analysis (NMA) of randomized controlled trials (SNO 2025) - "Compared to SysCT±RT (reference), logHRs (95%CI) for survival were: IT/ITV DepoCyt±SysCT±RT -0.094(-0.468,0.281); IT/ITV methotrexate(MTX)±cytarabine(AraC)±SysCT±RT 0.8567(0.066,1.647)...Disconnected-component-NMA demonstrated incremental logHR: AraC 0.539(-0.347,1.425); IT/ITV DepoCyt 0.052(-0.566,0.670); IT/ITV MTX 0.179(-0.484,0.840); ITV thiotepa 0.298(-0.767,1.362); proton CSI -0.250(-0.726,0.225)...Conclusions : IT/ITV DepoCyt±SysCT±RT and SysCT±RT were found to be the most effective regiments in this advanced, comparative analysis. However, a lack of significant incremental benefit with any specific therapy component warrants evaluating aspects of older regiments in contemporary RCTs."

Metastases • Retrospective data

Treatment strategies for patients with leptomeningeal metastatic disease (LMD): a network meta-analysis (NMA) of randomized controlled trials (WFNOS 2025) - "Compared to SysCT±RT (reference), logHRs (95%CI) for survival were: IT/ITV DepoCyt±SysCT±RT -0.094(-0.468,0.281); IT/ITV methotrexate(MTX)±cytarabine(AraC)±SysCT±RT 0.8567(0.066,1.647)...Disconnected-component-NMA demonstrated incremental logHR: AraC 0.539(-0.347,1.425); IT/ITV DepoCyt 0.052(-0.566,0.670); IT/ITV MTX 0.179(-0.484,0.840); ITV thiotepa 0.298(-0.767,1.362); proton CSI -0.250(-0.726,0.225)...Conclusions : IT/ITV DepoCyt±SysCT±RT and SysCT±RT were found to be the most effective regiments in this advanced, comparative analysis. However, a lack of significant incremental benefit with any specific therapy component warrants evaluating aspects of older regiments in contemporary RCTs."

Metastases • Retrospective data

Multicenter Pilot Trial of Intrathecal Liposomal Cytarabine Combined with FAB Chemoimmunotherapy with Reduced Doxorubicin in CAYA with Mature De-Novo B-NHL (ASH 2023) - "Standard therapy includes short but intensive courses of multiagent chemotherapy including CNS-penetrating high dose methotrexate and cytarabine for CNS penetration as well as vincristine, prednisone, doxorubicin, and cyclophosphamide with or without etoposide... By utilizing dexamethasone prophylaxis and waiting for systemic methotrexate clearance, we were able to demonstrate that IT LC in C-AYAs with MB-NHL who received FAB chemoimmunotherapy with HD MTX was feasible, safe, and did not compromise event free and overall survival. We were also able to reduce the total number of IT injections without apparent compromise to CNS prophylaxis and treatment."

Clinical • Anesthesia • B Cell Lymphoma • Burkitt Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Epilepsy • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Auto Stem Cell Transplant for Lymphoma Patients (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Indolent Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Sezary Syndrome • Transplantation • ALK • CD4 • TCL1A

Efficacy of EXPAREL vs. Bupivacaine (clinicaltrials.gov) - P3 | N=104 | Not yet recruiting | Sponsor: Emory University

New P3 trial • Orthopedics

O-ICE: Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: New York Medical College | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • CD20

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: M.D. Anderson Cancer Center | N=22 ➔ 0 | Trial completion date: Dec 2033 ➔ Jul 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2031 ➔ Jul 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Mar 2025 ➔ Apr 2030

Trial completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating with Decitabine in Pediatric Relapsed and Refractory Acute Leukemias (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center | Initiation date: Dec 2024 ➔ Dec 2025

Trial initiation date • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Navigating translational research in nanomedicine: A strategic guide to formulation and manufacturing. (PubMed, Int J Pharm) - "It provides an overview of the most prevalent manufacturing technologies and excipients used in nanomedicine production, followed by a critical evaluation of their clinical translatability. Furthermore, the review presents strategies for the rational formulation design and optimization of nanomedicine manufacturing, adhering to the principles of quality-by-design and quality risk management."

Journal • Review • CNS Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology

SCNSL1: High-dose Sequential Chemoimmunotherapy for B-cell Lymphomas With Central Nervous System Involvement (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Andrés José Maria Ferreri | Unknown status ➔ Completed

Trial completion • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

NCI-2022-03803: A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2025 ➔ Dec 2025

Trial completion date • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

INTRATHECAL LIPOSOMAL CYTARABINE AND REDUCED FAB CHEMOIMMUNOTHERAPY IN CAYA WITH MATURE DE-NOVO B-NHL; A MULTI-INSTITUTIONAL STUDY (SIOP 2024) - "Dexamethasone replaced prednisone to mitigate potential CNS toxicities.Results 33 eligible patients enrolled...Conclusions By using IT LC in C-AYA, we were able to reduce the number of IT injections required as part of therapy, in turn, decreasing the number of sedations, and potentially decreasing the risk of future cognitive deficits. We were able to show that by incorporating dexamethasone prophylaxis and waiting for systemic methotrexate clearance, the use of IT LC was feasible and safe, and did not negatively affect the 2-year EFS and OS (Figure 2)."

Clinical • Anesthesia • Burkitt Lymphoma • CNS Disorders • Cognitive Disorders • Leukemia • Non-Hodgkin’s Lymphoma

IELSG30: Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis (clinicaltrials.gov) - P2 | N=54 | Completed | Sponsor: International Extranodal Lymphoma Study Group (IELSG) | Active, not recruiting ➔ Completed

Trial completion • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1 trial • Hematological Malignancies • Leukemia • Oncology • Pediatrics

Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Medical College of Wisconsin | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ May 2024

Combination therapy • Trial completion • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Completed

Trial completion • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2 | N=70 | Terminated | Sponsor: Kartos Therapeutics, Inc. | Phase classification: P1b/2 ➔ P1/2 | Trial completion date: Jul 2024 ➔ Sep 2023 | Active, not recruiting ➔ Terminated; In September 2023, the study was terminated because of a Sponsor decision, unrelated to safety concerns.

Combination therapy • Phase classification • Trial completion date • Trial termination • Acute Myelogenous Leukemia • Essential Thrombocythemia • Hematological Malignancies • Leukemia • Myeloproliferative Neoplasm • Oncology • IDH1 • IDH2

Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2 | N=11 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed

Trial completion • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Feb 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

NCI-2022-03803: A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Feb 2024 ➔ Feb 2025

Combination therapy • Trial completion date • Trial primary completion date • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Intrathecal Therapy Options for Meningeal Carcinomatosis. (PubMed, Geburtshilfe Frauenheilkd) - "Methotrexate, liposomal cytarabine and trastuzumab are the most common substances used for intrathecal therapy. However, comprehensive studies which compare the efficacy and side effects of individual pharmaceuticals are lacking. Because of the poor prognosis associated with meningeal carcinomatosis, an approach which treats only the symptoms (best supportive care) should always be considered and discussed with affected patients."

Journal • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Medical College of Wisconsin

Combination therapy • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Medical College of Wisconsin | Trial primary completion date: Oct 2024 ➔ May 2024

Combination therapy • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology