A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

Roche

Status and phase: Completed; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Obinutuzumab; Drug: Fludarabine; Drug: Bendamustine; Drug: Cyclophosphamide; Drug: Chlorambucil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01905943

MO28543

2013-000087-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 979 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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979 participants in 1 patient group

Obinutuzumab

Experimental group

Description:

Participants will receive obinutuzumab either alone as single agent or in combination with chemotherapy (Fludarabine/Cyclophosphamide \[FC\], Bendamustine or Chlorambucil) at the investigator's discretion. Each cycle is of 28-days duration.

Treatment:

Drug: Fludarabine

Drug: Bendamustine

Drug: Obinutuzumab

Drug: Cyclophosphamide

Drug: Chlorambucil