- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059251
Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina
April 16, 2020 updated by: Hoffmann-La Roche
An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires
-
Buenos Aires, Argentina
- Clínica Peuyrredón
-
Buenos Aires, Argentina
- Hospital Municipal Teodoro Alvarez
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- Have received at least one dose of Obinutuzumab as per local label and clinical practice.
Exclusion Criteria:
- Included in clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obinutuzumab
All participants with chronic lymphocytic leukemia (CLL) who have received the indication for treatment with Obinutuzumab, as per routine clinical practice in Argentina.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
|
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)
Time Frame: Up to 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response Rate
Time Frame: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
|
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 g/dl and bone marrow at least normocellular for age.
|
Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
|
Partial Response Rate
Time Frame: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
|
PR was defined as >=50% decrease in peripheral blood lymphocyte count from the pre-treatment value, >/=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.
|
Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
|
Progression-free Survival (PFS)
Time Frame: After the completion of treatment, at 12 and 24 months after start of treatment
|
PFS is defined as the time from the first dose of treatment to the first occurrence of progression, or death from any cause as assessed by the physician.
Progressive disease is defined by any of the following: >/=50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, >/=50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/=50% increase in the enlargement of the liver and/or spleen, transformation to a more aggressive histology, after treatment, the progression of any cytopenia (a decrease of hemoglobin levels >2 g/dL or <10 g/dL or a decrease of platelet counts >50% or <100 x 10x9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L), excluding immune causes.
|
After the completion of treatment, at 12 and 24 months after start of treatment
|
Median Duration of Response
Time Frame: Up to 24 months
|
Duration of response is defined as the time from the date the response (either CR or PR) was first recorded until the date of disease progression or death due to any cause.
Disease progression is defined by any of the following: >/=50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, >/=50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/=50% increase in the enlargement of the liver and/or spleen, transformation to a more aggressive histology, after treatment, the progression of any cytopenia (a decrease of hemoglobin levels >2 g/dL or <10 g/dL or a decrease of platelet counts >50% or <100 x 10x9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L), excluding immune causes.
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 31, 2017
Primary Completion (ACTUAL)
March 30, 2019
Study Completion (ACTUAL)
March 30, 2019
Study Registration Dates
First Submitted
February 17, 2017
First Submitted That Met QC Criteria
February 17, 2017
First Posted (ACTUAL)
February 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 17, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML30187
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Lymphocytic Leukemia
-
National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingLeukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | Leukemia, Chronic Lymphatic | B-Cell Chronic Lymphocytic Leukemia | Leukemia, Lymphocytic, Chronic | B-Lymphocytic Leukemia, Chronic | Leukemia, Chronic Lymphocytic, B-Cell | Lymphocytic Leukemia, Chronic, B Cell | Lymphocytic Leukemia...United States
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)TerminatedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)TerminatedLeukemia | B-cell Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Celgene CorporationTerminatedChronic Lymphocytic Leukemia | B-cell Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
-
Roswell Park Cancer InstituteWithdrawnRefractory Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic Leukemia
-
Mayo ClinicNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia and other conditionsUnited States
Clinical Trials on Obinutuzumab
-
Institute of Hematology & Blood Diseases Hospital...RecruitingImmune Thrombocytopenia | TreatmentChina
-
Qianfoshan HospitalNot yet recruitingIdiopathic Membranous Nephropathy
-
Michael ChoiPharmacyclics LLC.Withdrawn
-
Institute of Hematology & Blood Diseases HospitalRecruitingImmune Thrombocytopenia | TreatmentChina
-
Hoffmann-La RocheCompletedFollicular Lymphoma | Chronic Lymphocytic LeukemiaKorea, Republic of
-
French Innovative Leukemia OrganisationHoffmann-La RocheRecruiting
-
The First Affiliated Hospital with Nanjing Medical...RecruitingObinutuzumab | Rapid Infusion | Intravenous Infusion ReactionChina
-
Fondazione Italiana Linfomi - ETSRoche Pharma AGRecruiting
-
Paolo GhiaRecruitingChronic Lymphocytic LeukemiaItaly
-
Polish Myeloma ConsortiumRoche Pharma AG; Bioscience, S.A.UnknownWaldenstrom MacroglobulinemiaPoland