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A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy +
A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy
Protocol No: 75276617AML3001
Age Group: Adult
Disease Sites: Myeloid and Monocytic Leukemia
NCT Id: NCT06852222
Phase: III
Principal Investigators: Juan Varela MD, PhD
Eligibility Document -
Attachment Id: 16972
File Name: Subject Eligibility _Screening Checklist_JNJ75276617AML3001.docx
URL:
Objective
The primary objective is to determine whether the addition of bleximenib to VEN+AZA significantly improves the dual primary endpoints of CR rate or OS compared with VEN+AZA in participants with ND KMT2Ar or NPM1mAML who are ineligible for intensive chemotherapy
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A Phase 2, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma +
A Phase 2, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination with Gemcitabine Plus Oxaliplatin in Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Protocol No: GO45434
Age Group: Adult
Disease Sites: Non-Hodgkin's Lymphoma
NCT Id: NCT06806033
Phase: II
Principal Investigators: Juan Varela MD, PhD
Eligibility Document -
Attachment Id: 14973
File Name: Subject Eligibility _Screening Checklist_GO45434.docx
URL:
Objective
This study will evaluate the optimization of the CRS profile for the Glofit-GemOx treatment regimen in patients with R/R DLBCL, using optimized regimen of steroids and a revised infusion and monitoring regimen to optimize the CRS profile of this treatment combination.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease +
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Protocol No: INCA34176-357
Age Group: Both
Disease Sites: Other Hematopoietic
NCT Id: NCT06585774
Phase: III
Principal Investigators: Juan Varela MD, PhD
Objective
To compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
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A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (KISIMA-02) +
A Phase 1B Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma (KISIMA-02)
Protocol No: KISIMA-02
Age Group: Adult
Disease Sites: Pancreas
NCT Id: NCT05846516
Phase: I
Principal Investigators: Omar Kayaleh, MD
Eligibility Document -
Attachment Id: 5231
File Name: Subject Eligibility _Screening Checklist KISIMA 02.docx
URL:
Objective
This study is testing a combination of new cancer-fighting drugs to see if they are safe and might help people with a specific type of pancreatic cancer (KRAS-mutated) live longer or delay the return of their cancer.
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A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE;FL-2) +
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE;FL-2)
Protocol No: M22-003
Age Group: Adult
Disease Sites: Non-Hodgkin's Lymphoma
NCT Id: NCT06191744
Phase: III
Principal Investigators: Jose Sarriera, MD
Eligibility Document -
Attachment Id: 6409
File Name: Subject Eligibility _Screening Checklist M22-003_Version 2.0 dated 09Feb2024.docx
URL:
Objective
This study is testing if a new drug combination (epcoritamab with rituximab and lenalidomide) works better than standard chemotherapy for adults with previously untreated follicular lymphoma.
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