UnknownNot Applicable

Gazyva Infusion Reaction Investigation

Russia104 participantsStarted 2018-03-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

MRD status of CLL patients with comorbidities

Timeframe: 3 months after the last dose of study treatment

Trial details

NCT IDNCT03529227

SponsorHealthy Future

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-31

Contact for this trial

Eugeny A Nikitin, MD

+7 916 572 06 eugene_nikitin@mail.ru

View on ClinicalTrials.gov More Chronic Lymphocytic Leukemia trials