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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01905943
• Date of registration: 19/07/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
• Scientific title: 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
• Date of first enrolment: November 4, 2013
• Target sample size: 979
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01905943
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Albania, Argentina, Belgium, Bosnia and Herzegovina, Brazil, Canada, Egypt, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Macedonia, The Former Yugoslav Republic of, Mexico, North Macedonia, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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 (
- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Lymphocytic Leukemia

Intervention(s)

Drug: Bendamustine

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: Chlorambucil

Drug: Obinutuzumab

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline up to time of primary completion (3 years)]

Number of Participants With Adverse Events of Particular Interest (AEPIs) [Time Frame: Baseline up to time of primary completion (3 years)]

Number of Participants With Adverse Events of Special Interest (AESIs) [Time Frame: Baseline up to time of primary completion (3 years)]

Secondary Outcome(s)

Median Time to Duration of Response (DoR) [Time Frame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)]

Median Time to Response (TTR) [Time Frame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)]

Median Time to Overall Survival (OS) [Time Frame: Baseline until death (Approximately up to 5 years)]

Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry [Time Frame: 3 months after the last dose of study treatment (up to approximately 5 years)]

Percentage of Participants With Best Overall Response (BOR) [Time Frame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)]

Median Time to Event-Free Survival (EFS) [Time Frame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)]

Median Time to New Anti-Leukemia Therapy (TTNT) [Time Frame: Baseline until end of study (up to approximately 5 years)]

Median Time to Progression-Free Survival (PFS) [Time Frame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)]

Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA) [Time Frame: 3 months after the last dose of study treatment (up to approximately 5 years)]

Secondary ID(s)

2013-000087-29

MO28543

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01905943