Resumen

This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Previously untreated documented CLL according to National Cancer Institute/international workshop on CLL (NCI/iwCLL) criteria OR relapsed and/or refractory documented CLL participants requiring treatment according to NCI/iwCLL criteria; participants with up to 3 relapses are eligible
Refractory participants if last treatment was with single-agent therapy, single-agent chemotherapy, or single-agent antibody
Participants with 17p-deletion and/or p53 mutation may be included at the investigator's discretion
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy greater than (\>) 6 months according to the investigator's opinion
Adequate hematological function

Criterios de exclusión

Participants who have received more than 3 previous CLL treatment lines
Documented transformation of CLL to aggressive lymphoma (Richter's transformation)
Participants who are refractory to immunochemotherapy
Participants with abnormal laboratory values
One or more individual organ/system impairment score of 4 as assessed by the cumulative illness rating scale (CIRS) definition, excluding the eyes, ears, nose, throat and larynx organ systems
Participants with a history of progressive multifocal leukoencephalopathy (PML)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Known hypersensitivity to the study drugs
History of prior malignancy unless the malignancy has been treated with a curative intent and in remission without treatment for greater than or equal to (\>/=) 5 years prior to enrollment and with the exception of curatively-treated basal cell carcinoma, squamous cell carcinoma of the skin, low grade in situ carcinoma of the cervix, or low grade, early stage localized prostate cancer treated surgically with curative intent
Regular treatment with corticosteroids during the 28 days prior to the start of Cycle 1, Day 1, unless administered for indications other than CLL at a dose equivalent to less than or equal to (\</=) 30 milligrams per day (mg/day) prednisone
Regular treatment with immunosuppressive medications following previous organ transplantation
Evidence of significant, uncontrolled concomitant diseases
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) or a major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to the start of Cycle 1, Day 1
Vaccination with live vaccines within 28 days prior to start of Cycle 1, Day 1
Major surgery (within 28 days prior to the start of Cycle 1, Day 1), other than for diagnosis
Positive for chronic hepatitis B, hepatitis C, human T-lymphotropic virus 1 (HTLV 1) or human immunodeficiency virus (HIV) infection
Pregnant or lactating women
Fertile men or women of childbearing potential
Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1, Day 1 and during the study

Intervenciones

drug

Bendamustine

Bendamustine: 90 milligram per millilitre square (mg/m\^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m\^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m\^2 in previously untreated participants, and bendamustine 50 mg/m\^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration).

drug

Chlorambucil

Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only.

drug

Cyclophosphamide

Cyclophosphamide 250 mg/m\^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m\^2 p.o. QD Day 1-3 in fit participants only.

drug

Fludarabine

Fludarabine 25 mg/m\^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m\^2 per os (p.o.) QD Day 1-3 in fit participants only.

drug

Obinutuzumab

Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.

A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Bendamustine

Chlorambucil

Cyclophosphamide

Fludarabine

Obinutuzumab

Ubicaciones

Hospital Iturraspe

Patrocinadores