Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Progression free survival (PFS) by the Kaplan-Meier method |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
It is expected to include 104 patient with primary diagnosed CLL elder 18 years with certain comorbidities as any cardiac pathology/ diabetes mellitus/ kidney pathology/ cytopenia (Hb <100 g/l, Platelets < 100 x 109/l) after Obinutuzumab + chlorambucil are applied as the 1st line treatment .
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eugeny A Nikitin, MD | Contact | +7 916 572 06 | eugene_nikitin@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Eugeny A Nikitin, MD | "The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department". | Recruiting | Moscow | 125284 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Под ред. А.Д. Каприна, В.В. Старинского, Г.В. Петровой, "Злокачественные новообразования в России в 2015 году (заболеваемость и смертность)" - М.: МНИОИ им. П.А. Герцена - филиал ФГБУ "НМИРЦ" Минздрава России - 2017. - ил. - 250 с. ISBN 978-5-85502-227-8. | ||
| Result | Российские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний. Под руководством профессора И.В. Поддубной, профессора В.Г. Савченко. М., 2016. - 412 с. | ||
| 27697770 | Result | 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. doi: 10.1182/blood-2016-05-714162. Epub 2016 Oct 3. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department | Recruiting | Moscow | 125284 | Russia |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |