Gazyva Infusion Reaction Investigation (GAIRI)
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|ClinicalTrials.gov Identifier: NCT03529227|
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : September 15, 2020
|Condition or disease|
|Chronic Lymphocytic Leukemia|
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.
|Study Type :||Observational|
|Estimated Enrollment :||104 participants|
|Official Title:||Prospective One-center Open Label Observational Efficacy & Safety Study of Chlorambucil & Obinutuzumab in Treatment of Unfit Patients With Untreated Chronic Lympho Leukemia With Comorbidities|
|Actual Study Start Date :||March 31, 2018|
|Estimated Primary Completion Date :||August 31, 2024|
|Estimated Study Completion Date :||April 30, 2025|
- MRD status of CLL patients with comorbidities [ Time Frame: 3 months after the last dose of study treatment ]Number of patients with positive and negative MRD status
- Response Rate (ORR) [ Time Frame: 3 months after last dose administration ]Frequency of the overall response in patients with CLL using the Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (N,%)
- Progression free survival (PFS) by the Kaplan-Meier method [ Time Frame: 3 months after last dose administration ]Time to full remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method
- Duration of response (DOR) by the Kaplan-Meier method [ Time Frame: 3 months after last dose administration ]Time to partial remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529227
|Contact: Eugeny A Nikitin, MD||+7 916 572 email@example.com|
|The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department".||Recruiting|
|Moscow, Russian Federation, 125284|
|Contact: Eugeny A Nikitin, MD|
|The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department||Recruiting|
|Moscow, Russian Federation, 125284|
|Principal Investigator:||Eugeny A Nikitin, MD||"The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department"|