Observational Study of Ibrutinib Use in CLL

Status Recruiting

Clinical Trial Summary

IB-RU-SCOPE is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation

Clinical Trial Description

Ibrutinib is approved in Russia for treatment of CLL patients both in first line and in relapsed/refractory setting. There is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient selection in the former. IB-RU-SCOPE is a first "routine-clinical practice" oriented cohort observational study of ibrutinib in CLL in Russia. The study is designed to include all previously untreated and relapsed/refractory CLL patients older than 18 years with active disease, who have recently started or are about to start ibrutinib (both as monotherapy and in combination), and to follow them to a minimum of 18 and a maximum of 36 months. The study is being conducted in approx. 10 Russian hematological centers and aims to include approx. 70 CLL patients. ;

Study Design

Related Conditions & MeSH terms

Chronic Lymphocytic Leukemia
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid

Clinical Trial Details

NCT number	NCT03633045
Study type	Observational
Source	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Contact	Andrey Zaritskey, MD, PhD
Phone	0078127023765
Email	ibruscope@ya.ru
Status	Recruiting
Phase
Start date	September 1, 2018
Completion date	April 30, 2022

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