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A Safety And Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participant With Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01905943
First received: July 19, 2013
Last updated: May 29, 2017
Last verified: May 2017
  Purpose
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). 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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: Bendamustine Drug: Chlorambucil Drug: Cyclophosphamide Drug: Fludarabine Drug: Obinutuzumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Abinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0) [ Time Frame: Baseline up to end of study (Approximately 5 years) ]

Secondary Outcome Measures:
  • Number 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 5 years) ]
  • Percentage of participants with overall response as determined by the investigator [ Time Frame: 3 months after the last dose of study treatment (up to 5 years) ]
  • 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 5 years total) ]
  • 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 5 years total) ]
  • Event-free survival (EFS) as assessed by the investigator [ 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 5 years total) ]
  • Percentage of participants with best overall response (BOR) as determined by the investigator [ 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 5 years total) ]
  • Overall survival (OS) [ Time Frame: Baseline until death (Approximately up to 5 years) ]
  • Time to new anti-leukemia therapy (TTNT) [ Time Frame: Baseline until end of study (Approximately up to 5 years) ]
  • 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 5 years total) ]

Enrollment: 979
Actual Study Start Date: November 30, 2013
Estimated Study Completion Date: October 25, 2018
Primary Completion Date: December 29, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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.
Drug: Bendamustine
Participants will receive bendamustine everyday (qd) on Days 1 to 2 of each 28-day cycle from Cycle 1 to Cycle 6 as per invetigator's discretion.
Drug: Chlorambucil
Participants will receive clorambucil qd on Days 1 and 15 of each 28-day cycle from Cycle 1 to Cycle 6 as per invetigator's discretion.
Drug: Cyclophosphamide
Participants will receive cyclophosphamide qd on Days 1 to 3 of each 28-day cycle from Cycle 1 to Cycle 6 as per invetigator's discretion.
Drug: Fludarabine
Participants will receive fludarabine qd on Days 1 to 3 of each 28-day cycle from Cycle 1 to Cycle 6 as per invetigator's discretion.
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.
Other Name: RO5072759

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 system
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905943

  Show 182 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01905943     History of Changes
Other Study ID Numbers: MO28543
2013-000087-29 ( EudraCT Number )
Study First Received: July 19, 2013
Last Updated: May 29, 2017

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Cyclophosphamide
Fludarabine phosphate
Bendamustine Hydrochloride
Chlorambucil
Fludarabine
Obinutuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on September 21, 2017