Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MRD status of CLL patients with comorbidities
- timeFrame
- 3 months after the last dose of study treatment
- description
- Number of patients with positive and negative MRD status
Secondary outcomes (3)
- measure
- Response Rate (ORR)
- timeFrame
- 3 months after last dose administration
- description
- Frequency of the overall response in patients with CLL using the Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (N,%)
- measure
- Progression free survival (PFS) by the Kaplan-Meier method
- timeFrame
- 3 months after last dose administration
- description
- Time to full remission in patients with CLL using Chlorambucil + Obinutuzumab (G-Clb) therapy regimen (month) calculated by the Kaplan-Meier method
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTПод 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.
- RESULTРоссийские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний. Под руководством профессора И.В. Поддубной, профессора В.Г. Савченко. М., 2016. - 412 с.
- RESULTKwok 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. PMID 27697770