Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059251
• Other study ID #: ML30187
• Status: Completed
• Start date: August 31, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Included in clinical trial

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Biological:
• Obinutuzumab
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.

Locations

Country	Name	City	State
Argentina	Clínica Peuyrredón	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital Municipal Teodoro Alvarez	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Complete Response Rate	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)
Secondary	Partial Response Rate	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)
Secondary	Progression-free Survival (PFS)	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
Secondary	Median Duration of Response	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