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Clinical Trial News

NIH's Novel Five-Drug Combination Shows Promise for Relapsed Aggressive B-Cell Lymphoma

Targeted TherapyOncologyMonoclonal Antibody
  • NIH researchers have developed ViPOR, a non-chemotherapy five-drug regimen that achieved complete remission in 38% of patients with relapsed or refractory diffuse large B-cell lymphoma.
  • The treatment was particularly effective in two specific subtypes: non-GCB DLBCL (62% complete response) and double-hit GCB DLBCL (53% complete response), offering new hope for patients with limited options.
  • At the two-year mark, 36% of all treated patients were still alive and 34% remained disease-free, with some maintaining remission beyond four years despite previously facing poor prognoses.

CALQUENCE Plus Chemoimmunotherapy Shows 27% Reduction in Disease Progression Risk for Untreated Mantle Cell Lymphoma

  • The ECHO Phase III trial demonstrated that CALQUENCE (acalabrutinib) combined with bendamustine and rituximab significantly reduced disease progression or death risk by 27% compared to standard chemoimmunotherapy in previously untreated mantle cell lymphoma patients.
  • Patients receiving the CALQUENCE combination experienced a median progression-free survival of 66.4 months versus 49.6 months with standard care, representing an additional 16.8 months without disease progression.
  • The safety profile was consistent with previous CALQUENCE studies, with no new safety signals identified, positioning this combination as a potential new first-line treatment option for MCL patients.

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT01776840CompletedPhase 3
Janssen Research & Development, LLC
Posted 5/16/2013

Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

NCT03824483RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 2/22/2019

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

NCT02972840Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 4/5/2017

IASO Bio's CAR-T Therapy Shows 100% Response Rate in High-Risk Newly Diagnosed Multiple Myeloma Patients

CAR-T
  • IASO Bio presented clinical data showing Equecabtagene Autoleucel achieved 100% overall response rate with 93.8% stringent complete response in high-risk newly diagnosed multiple myeloma patients ineligible for transplant.
  • The FUMANBA-2 study demonstrated all 16 patients achieved minimal residual disease negativity, with 71.4% maintaining this status for over 12 months and a 12-month progression-free survival rate of 84.4%.
  • Safety profile showed 68.8% incidence of grade 1-2 cytokine release syndrome with no grade 3 or higher CRS events and no neurotoxicity, representing the world's first CAR-T therapy used as first-line treatment in this patient population.

Roche's Columvi Demonstrates 41% Reduction in Death Risk in Phase III DLBCL Trial

OncologyDrug Approval
  • Roche's Phase III STARGLO study showed Columvi plus chemotherapy reduced death risk by 41% versus rituximab plus chemotherapy in relapsed/refractory diffuse large B-cell lymphoma patients.
  • The combination achieved a median overall survival of 25.5 months compared to 12.9 months for the control arm, with complete response rates of 58.5% versus 25.3%.
  • Results position Columvi as the first CD20xCD3 bispecific antibody to demonstrate survival benefit in DLBCL in a randomized Phase III trial.
  • The data will be submitted to global health authorities including FDA and EMA to support conversion from accelerated to full approval.

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080RecruitingPhase 3
Hoffmann-La Roche
Posted 9/18/2023

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 2/23/2021

Disitamab Vedotin Plus Toripalimab Shows Promise in HER2-Positive Muscle-Invasive Bladder Cancer

• Neoadjuvant disitamab vedotin plus toripalimab demonstrates a 61.3% pathological complete response rate in patients with operable HER2-positive muscle-invasive bladder cancer (MIBC). • The combination therapy showed an 85% event-free survival rate at 12 months, indicating a potential for improved clinical outcomes in this patient population. • Treatment-related adverse events were generally mild, with the most common being alopecia, elevated liver enzymes, and rash, suggesting a manageable safety profile. • The ongoing phase 2 study anticipates final completion in February 2025, with further data expected to refine the understanding of long-term efficacy and safety.

A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

NCT05297552RecruitingPhase 2
RemeGen Co., Ltd.
Posted 5/26/2022

Liso-Cel CAR-T Therapy Shows Promising Results Across Multiple Lymphoma Subtypes

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrates clinically meaningful activity across various lymphoma subgroups, including mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.
  • In relapsed/refractory mantle cell lymphoma patients, liso-cel achieved a median overall survival of 13.5 months and progression-free survival of 7.4 months despite heavy pretreatment.
  • Follicular lymphoma patients show particularly stellar response rates with durable complete remissions lasting nearly 3 years of follow-up.
  • Experts advocate for exploring liso-cel use in earlier treatment lines, particularly for high-risk patient subgroups who may benefit from better-preserved T-cell health.

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

Disc Medicine Presents Positive Clinical Data Across Portfolio

Disc Medicine announced positive clinical data from its portfolio, including bitopertin for erythropoietic protoporphyria (EPP), DISC-0974 for myelofibrosis (MF) anemia, and DISC-3405 in healthy volunteers, showcasing significant advancements in treatment options for hematologic diseases.

Lixte Biotechnology and Netherlands Cancer Institute Partner to Trial LB-100 in Metastatic Colon Cancer

  • Lixte Biotechnology partners with the Netherlands Cancer Institute to evaluate LB-100 in metastatic colon cancer patients.
  • The clinical trial will combine LB-100 with atezolizumab, a PD-L1 inhibitor, to enhance the immune response against cancer cells.
  • Lixte will supply LB-100, while Roche will provide atezolizumab and fund the trial, with no clinical costs for Lixte.
  • The trial includes a dose escalation phase followed by clinical activity and safety assessment in up to 37 patients over 24 months.

FDA Approves Blinatumomab for CD19-Positive B-ALL Consolidation Phase

  • The FDA has approved blinatumomab for treating CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase.
  • The approval is supported by the Phase 3 ECOG-ACRIN E1910 study, which showed superior overall survival with blinatumomab plus chemotherapy compared to chemotherapy alone.
  • Another Phase 3 study, 20120215, demonstrated that blinatumomab led to a significantly higher 5-year overall survival rate compared to intensive chemotherapy in pediatric and young adult patients.
  • Blinatumomab, a Bispecific T-cell Engager (BiTE®) therapy, is now a standard of care, offering a more effective treatment option than chemotherapy alone for B-ALL patients.

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

NCT02003222Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 5/19/2014

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

NCT02393859CompletedPhase 3
Amgen
Posted 11/10/2015

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

NCT02101853Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 12/17/2014

Camrelizumab Shows Promise in Initially Unresectable NSCLC

  • A phase 2 study evaluates camrelizumab plus chemotherapy or apatinib as neoadjuvant therapy for initially unresectable stage II-III NSCLC.
  • Camrelizumab with chemotherapy led to surgical resection in 50% of patients, with a major pathological response rate of 20%.
  • Camrelizumab plus apatinib resulted in surgery in 42.9% of patients, achieving a major pathological response rate of 55.6% in PD-L1 positive cases.
  • The study suggests neoadjuvant camrelizumab-based therapies may convert unresectable NSCLC into resectable disease with manageable toxicity.

Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer

NCT04379739Active, Not RecruitingPhase 2
Shanghai Pulmonary Hospital, Shanghai, China
Posted 7/26/2020

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