NCT03059251

Brief Summary

This observational study aims to study the effectiveness and safety of Obinutuzumab in common clinical practice settings in Argentina. The study population comprises all patients with chronic lymphocytic leukemia (CLL) that have received the indication for treatment with Obinutuzumab as per routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

3 active sites

Status
completed

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

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 31, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.6 years

First QC Date

February 17, 2017

Last Update Submit

April 16, 2020

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL, obinutuzumab, treatment

Outcome Measures

Primary Outcomes (2)

  • Overall Response Rate

    Overall response rate was defined as percentage of participants with complete response (CR) or partial response (PR). CR was defined as peripheral blood lymphocytes below 4 x 10\^9/liter (L), absence of significant lymphadenopathy, no hepatomegaly, no splenomegaly, absence of disease or B symptoms, neutrophils \>1.5 x 10\^9/L, platelets \>100 x 10\^9/L, hemoglobin \>11 grams/deciliter (g/dl) and bone marrow at least normocellular for age. PR was defined as \>=50% decrease in peripheral blood lymphocyte count, \>/=50% reduction in lymphadenopathy, \>/=50% reduction of liver enlargement and/or \>/=50% reduction of spleen enlargement, plus at least one of the following: neutrophils \>1.5 x 10\^9/L or \>/=50% increase, or platelets \>100 x 10\^9/L or ≥50% increase, or hemoglobin 11 g/dl or \>/=50% increase. Overall response rate = CR + PR

    Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)

  • Percentage of Participants With Adverse Events (AEs)

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Up to 24 months

Secondary Outcomes (4)

  • Complete Response Rate

    Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)

  • Partial Response Rate

    Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)

  • Progression-free Survival (PFS)

    After the completion of treatment, at 12 and 24 months after start of treatment

  • Median Duration of Response

    Up to 24 months

Study Arms (1)

Obinutuzumab

All participants with chronic lymphocytic leukemia (CLL) who have received the indication for treatment with Obinutuzumab, as per routine clinical practice in Argentina.

Biological: Obinutuzumab

Interventions

ObinutuzumabBIOLOGICAL

Obinutuzumab will be administered as intravenous infusion for 6 cycles (28 days per cycle): 100 milligrams (mg) on day 1 Cycle 1, 900 mg on day 2 Cycle 1, 1000 mg on days 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6.

Also known as: Gazyva®
Obinutuzumab

Eligibility Criteria

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

All patients with chronic lymphocytic leukemia (CLL) who have received the indication for treatment with Obinutuzumab as per routine clinical practice in Argentina.

You may qualify if:

  • Have received at least one dose of Obinutuzumab as per local label and clinical practice.

You may not qualify if:

  • Included in clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clínica Peuyrredón

Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Municipal Teodoro Alvarez

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

obinutuzumab

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

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

August 31, 2017

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

AR(3)