Gazyva Infusion Reaction Investigation

Chronic Lymphocytic Leukemia Clinical Trial

— GAIRI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03529227
• Other study ID #: ML40194
• Status: Recruiting
• Start date: March 31, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2022
• Source: Healthy Future
• Contact: Eugeny A Nikitin, MD
• Phone: +7 916 572 06
• Email: eugene_nikitin[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: April 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. CD20+/ (cluster of differentiation antigen 20 positive) B-CLL pts on the 1st line treatment therapy, whom have been already applied Obinutuzumab and chlorambucil

2. Age = 18 years.

3. Eastern Cooperative Oncology Group Scale (ECOG) 0-2.

4. Total Chronic Illness Resources Survey scale (CIRS) score >6 or creatinine clearance <70 ml/min or both for patients = 18 years old or all CLL pts = 75 years old

5. Any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb <100 g/l, Platelets < 100 x 109/l)

6. Life expectancy more than 6 months according to the physician's opinion.

7. Signed informed consent that allow personal data and data that refer to patient confidentiality processing

Exclusion Criteria:

The refusal of the patient to participate in the observational study and the withdrawal of informed consent that allow processing of personal data and data that refer to patient confidentiality.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell

Locations

Country	Name	City	State
Russian Federation	The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department	Moscow
Russian Federation	The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department".	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Healthy Future

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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Kwok M, Rawstron AC, Varghese A, Evans PA, O'Connor SJ, Doughty C, Newton DJ, Moreton P, Hillmen P. Minimal residual disease is an independent predictor for 10-year survival in CLL. Blood. 2016 Dec 15;128(24):2770-2773. Epub 2016 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRD status of CLL patients with comorbidities	Number of patients with positive and negative MRD status	3 months after the last dose of study treatment
Secondary	Response Rate (ORR)	Frequency of the overall response in patients with CLL using the Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (N,%)	3 months after last dose administration
Secondary	Progression free survival (PFS) by the Kaplan-Meier method	Time to full remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method	3 months after last dose administration
Secondary	Duration of response (DOR) by the Kaplan-Meier method	Time to partial remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method	3 months after last dose administration