NCT03529227

Gazyva Infusion Reaction Investigation

Prospective One-center Open Label Observational Efficacy & Safety Study of Chlorambucil & Obinutuzumab in Treatment of Unfit Patients With Untreated Chronic Lympho Leukemia With Comorbidities

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 104 (estimated)
• Sponsor: Healthy Future · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluate safety and effectiveness of chlorambucil and obinutuzumab in routine clinical practice in patients with chronic lymphatic leukemia and with certain comorbidities (any cardiac pathology, diabetes mellitus (DM), kidney pathology or cytopenia), whom obinutuzumab \& chlorambucil have been applied according to indications before enrollment in the study.

Detailed description

MRD (Minimal residual disease) evaluation was chosen as a primary measure outcome as it is considered as prognostic marker for long-term progression freee survival (PFS) and as a potential therapeutic goal in chronic lymphocytic leukemia/ CLL . Minimal residual disease (MRD-negative) is assessed in the clinic by 8-color flow cytometry giving the sensitivity level of MRD detection 10-5; MRD is measured in real clinical practice at this clinical center according to National recommendations in diagnostics and treatment of lymphoproliferative disorders. To achieve study objectives medical patients' charts will be analyzed retrospectively. In the frame of this program 104 patients' charts treated in defined clinical site, are planned to be analyzed. This number of patients corresponds to the patient flow with this pathology at a defined clinical site for 1 years. Data collection is considered to be retrospective as data will be transferred to e-CRF from patient medical charts. During this study no further specific extra procedures for data gathering is expected. But since patients included in the study will be at the center of ongoing therapy, the study was called a prospective.

Conditions

• Chronic Lymphocytic Leukemia

Timeline

• Start date: 2018-03-31
• Primary completion: 2024-08-31
• Completion: 2025-04-30
• First posted: 2018-05-18
• Last updated: 2022-02-14

Locations

2 sites across 1 country: Russia