Gazyva Infusion Reaction Investigation

  • STATUS
    Recruiting
  • End date
    Apr 30, 2025
  • participants needed
    104
  • sponsor
    Healthy Future
Updated on 25 January 2021
cytopenia
cluster of differentiation
chlorambucil
obinutuzumab

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.

Details
Condition Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma
Clinical Study IdentifierNCT03529227
SponsorHealthy Future
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

CD20+/ (cluster of differentiation antigen 20 positive) B-CLL pts on the 1st line treatment therapy, whom have been already applied Obinutuzumab and chlorambucil
Age 18 years
Eastern Cooperative Oncology Group Scale (ECOG) 0-2
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
Any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb <100 g/l, Platelets < 100 x 109/l)
Life expectancy more than 6 months according to the physician's opinion
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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