NCT03529227

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

6.4 years

First QC Date

March 29, 2018

Last Update Submit

February 11, 2022

Conditions

Chronic Lymphocytic Leukemia

Keywords

chlorambucilobinutuzumab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Response Rate (ORR)

    3 months after last dose administration

  • Progression free survival (PFS) by the Kaplan-Meier method

    3 months after last dose administration

  • Duration of response (DOR) by the Kaplan-Meier method

    3 months after last dose administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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 .

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department".

Moscow, 125284, Russia

RECRUITING

The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department

Moscow, 125284, Russia

RECRUITING

Related Publications (3)

  • 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.

    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.

    PMID: 27697770RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eugeny A Nikitin, MD

    "The State Budgetary Moscow Healthcare Institution Clinical Hospital named after S.P. Botkin of Moscow Health Department"

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugeny A Nikitin, MD

CONTACT

+7 916 572 06eugene_nikitin@mail.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

May 18, 2018

Study Start

March 31, 2018

Primary Completion

August 31, 2024

Study Completion

April 30, 2025

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

RU(2)