Mar 15th, 2023 - Phase Ia: To observe the safety and tolerability of GNC-038 in patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL)/relapsed or refractory acute lymphoblastic leukemia (R/R ALL), To determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and dose-limiting toxicity (DLT) of GNC-038 without MTD and recommend the dose for subsequent clinical studies. Phase Ib...

Mar 13th, 2023 - PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple m...

Mar 10th, 2023 - Despite the concerns of FDA staff, agency advisors endorsed the inclusion of polatuzumab vedotin (Polivy) in a modified version of R-CHOP for adults with previously untreated large B-cell lymphoma. By a vote of 11-2 on Thursday, the agency's Oncologic Drugs Advisory Committee (ODAC) said findings from the phase III POLARIX trial supported a favorable risk-benefit assessment for including the CD...

Mar 10th, 2023 - This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.

Mar 10th, 2023 - The study is divided into a phase I dose escalation phase and a phase II expansion phase. Patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL) will receive GDA-201 followed by a short course of low-dose interleukin-2 (IL-2). Rituximab will be administered prior to and after GDA-201 infusion. Phase I: Dose escal...

Mar 10th, 2023 - Background: Non-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV (PLWH) in the United States. Even in the modern era of antiretroviral therapy (ART), PLWH have an 11- to 17-fold higher risk of NHL than the general population due in part to CD4+ T-cell lymphopenia but also immune dysregulation and exhaustion from chronic viral antigen stimulation. The most common NHL...

Mar 10th, 2023 - Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refr...

Mar 10th, 2023 - Background: Despite improvements in therapy, acute lymphoblastic leukemia (ALL) contributes to significant morbidity and mortality for children and young adults with cancer. CD19-CAR and CD22-CAR therapy have proven highly effective in inducing remission in patients with relapsed/refractory disease. Immune escape has been observed by several groups following CD19-CAR and CD22- CAR therapy for B...

Mar 10th, 2023 - This is an investigator-initiated open-label multi-institutional phase I study of venetoclax combination therapy in both myeloid and lymphoid hematologic malignancies. This study is designed as a basket trial with three separate cohorts. All cohorts include a dose finding portion (Part I) followed by a dose expansion at the Recommended Phase II dose (RP2D, Part II). This research study is looki...

Mar 10th, 2023 - Background: High unmet medical need for relapsed/refractory non-Hodgkin lymphoma (NHL) after exhausting chemotherapy and/or chemo-immunotherapy regimens Targeted therapies aimed at disrupting cell death pathway in hematologic malignancies are emerging and showing significant activity in both the relapsed and first-line settings VIP152 is a selective inhibitor of PTEFb/CDK9 and is expected to sh...

Mar 10th, 2023 - This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.

Mar 10th, 2023 - PRIMARY OBJECTIVE: I. To evaluate the ability of ibrutinib-based induction therapy to prolong progression free survival (PFS) compared to standard fludarabine phosphate, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy for younger patients with chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. Evaluate overall survival (OS) of patients based on treatment arm. II. Monitor and ...

Mar 10th, 2023 - Background: Indolent B-cell malignancies are associated with frequent disease relapse Standard frontline therapy includes a monoclonal anti-CD20 antibody with or without chemotherapy; novel targeted therapies have changed the treatment landscape and are preferred therapy for some patients with high-risk molecular features Targeted therapies given indefinitely add to drug resistance, treatment-e...

Mar 10th, 2023 - This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell tra...

Mar 10th, 2023 - Hodgkin lymphoma (HL) survivors being following at St. Jude within the SJLIFE protocol cohort who were treated with TRT will be recruited to complete a comprehensive neurocognitive evaluation, overnight polysomnography evaluation, brain and neck MRI, cervical strength testing, and serum biomarkers related to cardiac disease. As part of their standard SJLIFE evaluation, they will also complete a...

Mar 10th, 2023 - PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with samotolisib (LY3023414) with advanced solid tumors, non-Hodgkin lymphomas or central nervous system (CNS) tumors that harbor TSC loss of function mutations, and/or other PI3K/MTOR activating mutations. SECONDARY OBJECTIVES: I. To estimate the progression ...

Mar 10th, 2023 - PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with larotrectinib sulfate (LOXO-101 [larotrectinib]) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders harboring NTRK 1/2/3 fusions. SECONDARY OBJECTIVES: I. To estimate the progression ...

Mar 10th, 2023 - Background: The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population, and about 2/3 of the complete responders appear to have prolonged disease-free survival. The present study assesses the activity and tolerability in previously untreated patients of a regimen of EPOCH inf...

Mar 10th, 2023 - PRIMARY OBJECTIVE: I. Positron mission tomography (PET)/computed tomography (CT) complete response (CR)/peripheral blood minimal residual disease (MRD) negative rate. SECONDARY OBJECTIVES: I. Progression-free survival at 36 months. II. Toxicity rates (incidence of grade 3/4 infections, renal and neurologic toxicities, cumulative dose of cytarabine & acalabrutinib, dose reduction, and treatment ...

Mar 10th, 2023 - PRIMARY OBJECTIVES: I. To determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99). II. To estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and Arm crizotinib (CZ) and contrast these to historical...