ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies

Status Withdrawn

Clinical Trial Summary

This research is studying the safety of combining ibrutinib with the study drug LY3214996 for chronic lymphocytic leukemia (CLL), Waldenstrom's macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL).

Clinical Trial Description

This research study is a Phase I clinical trial, which tests the safety of an investigational combination of drugs and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease.

The U.S. Food and Drug Administration (FDA) has approved ibrutinib as a treatment option for this disease.

LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor that is being developed as a treatment for patients with advanced cancer. ERK inhibitors stop the signal that a cancer cell receives telling it to grow. In this research study, the investigators are testing to see if LY3214996 is safe when combined with ibrutinib in patients with specific gene mutations. Making treatment decisions based on genetic testing is investigational, and the FDA has not approved this genetic testing. Several doses of LY3214996 will be explored in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04043845
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Withdrawn
Phase	Phase 1
Start date	February 3, 2020
Completion date	February 3, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Enrolling by invitation	`NCT01804686` - A Long-term Extension Study of PCI-32765 (Ibrutinib)	Phase 3
Completed	`NCT02057185` - Occupational Status and Hematological Disease
Active, not recruiting	`NCT04240704` - Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL	Phase 1
Recruiting	`NCT03676504` - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR	Phase 1/Phase 2
Active, not recruiting	`NCT03280160` - Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab	Phase 2
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Completed	`NCT00038025` - A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies	Phase 2
Recruiting	`NCT04904588` - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	Phase 2
Terminated	`NCT02231853` - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections	Phase 1
Recruiting	`NCT05417165` - Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia	Phase 2
Recruiting	`NCT04028531` - Understanding Chronic Lymphocytic Leukemia
Completed	`NCT00001637` - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults	Phase 2
Completed	`NCT02910583` - Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)	Phase 2
Completed	`NCT01527045` - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies	Phase 2
Recruiting	`NCT04679012` - Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation	Phase 2
Recruiting	`NCT05405309` - RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia	Phase 1/Phase 2
Active, not recruiting	`NCT05023980` - A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)	Phase 3
Recruiting	`NCT04553692` - Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers	Phase 1
Completed	`NCT04666025` - SARS-CoV-2 Donor-Recipient Immunity Transfer