Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 January 2019 |
Main ID: |
EUCTR2013-000087-29-LT |
Date of registration:
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28/01/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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International study evaluating safety of Obinutuzumab alone or in combination with chemotherapy in patients with Chronic Lymphocytic Leukemia.
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Scientific title:
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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:
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08/04/2014 |
Target sample size:
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950 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000087-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Albania
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Argentina
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Belgium
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Bosnia and Herzegovina
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Brazil
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Canada
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China
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Denmark
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Egypt
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Estonia
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Finland
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France
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Germany
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Greece
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Ireland
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Israel
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Macedonia, the former Yugoslav Republic of
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Mexico
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Slovakia
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Slovenia
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Spain
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Sweden
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Switzerland
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Thailand
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Uruguay
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4051
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd. |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4051
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Documented CLL either previously untreated or relapsed and/or refractory
• Age = 18 years
• ECOG performance status 0–2
• Adequate haematological function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 629 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 321
Exclusion criteria: • Patients who have received more than 3 previous CLL treatment lines
• Documented transformation of CLL to aggressive lymphoma (Richter’s transformation)
• Patients who are refractory to immunochemotherapy
• Calculated CrCl < 30 mL/min, or AST or ALT > 2.5 × ULN, or Total bilirubin = 3 × ULN
• One or more individual organ/system impairment score of 4 as assessed by the CIRS definition
• Patients with a history of progressive multifocal leukoencephalopathy (PML)
• Regular treatment (i.e. more than 5 consecutive days) with corticosteroids during the 4 weeks prior to the start of Cycle 1, Day 1, unless administered for indications other than CLL at a dose equivalent to = 30 mg/day prednisone
• Regular treatment with immunosuppressive medications following previous organ transplantation
• Vaccination with live vaccines within 28 days prior to start of treatment
• Positive test results for chronic hepatitis B, hepatitis C infections (HCV antibody are eligible only if PCR is negative for HCV RNA), positive test results (serology) for HIV, positive test results for HTLV 1 (un endemic areas)
• Women that are pregnant or lactating
• Fertile men or women of childbearing potential unless: (1) surgically sterile or (for women) = 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method, during study and for 12 months (females) or 6 months (males) after end of treatment
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Chronic lymphocytic leukemia MedDRA version: 20.1
Level: LLT
Classification code 10008976
Term: Chronic lymphocytic leukemia
System Organ Class: 100000004864
MedDRA version: 20.0
Level: LLT
Classification code 10008977
Term: Chronic lymphocytic leukemia recurrent
System Organ Class: 100000004864
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Intervention(s)
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Trade Name: Gazyvaro Product Name: OBINUTUZUMAB Product Code: RO5072759 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: OBINUTUZUMAB CAS Number: 949142-50-1 Current Sponsor code: RO5072759 Other descriptive name: OBINUTUZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
Trade Name: Levact Product Code: RO5469113 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE CAS Number: 3543-75-7 Current Sponsor code: RO5469113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Secondary Objective: • To evaluate the efficacy of obinutuzumab alone or in combination with chemotherapy in patients with previously untreated or relapsed/refractory, CLL, as measured by: - Minimal residual disease (MRD)-negativity 3 months after the last dose (i.e. at final response assessment visit) - Overall response rate (ORR) at time of final response assessment visit - Progression-free survival (PFS) - Time to Response (TTR) - Event-free survival (EFS) - Best overall response (BOR) - Overall survival (OS) - Time to new anti-leukemia therapy (TTNT) - Duration of response (DoR)
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Main Objective: • To evaluate the safety and tolerability of obinutuzumab alone or in combination with chemotherapy
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Primary end point(s): • To evaluate the safety and tolerability of obinutuzumab alone or in combination with chemotherapy • Incidence, type, and severity of all adverse events (AEs), based on the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE, v4.0) • Serious adverse events (SAEs) • AEs of special interest (AESIs; AEs associated with any obinutuzumab infusion [defined as any serious treatment-related AEs occurring during or within 24 hours of an obinutuzumab infusion], serious infections, serious neutropenia, and tumor lysis syndrome) • Dose delays/discontinuations • Abnormalities identified through physical examinations, vital signs, and laboratory assessments
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Timepoint(s) of evaluation of this end point: Assessed at each visit: screening, days 1, 2, 8, 15, 29, 57, 85, 113, 141 during treatment, 169 then 225 and every 3 months until the end of study.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Assessed at: screening, day 85 during treatment, 169 then 225 and every 3 months until the end of study.
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Secondary end point(s): • To evaluate the efficacy of obinutuzumab alone or in combination with chemotherapy, as measured by:
- Minimal residual disease (MRD)-negativity by flow cytometry 3 months after last dose (i.e. at final response assessment visit).
- Overall response rate (ORR) at time of final response assessment visit
- Progression-free survival (PFS)
- Time to Response (TTR)
- Event-free survival (EFS)
- Best overall response (BOR)
- Overall survival (OS)
- Time to new anti-leukemia therapy (TTNT)
- Duration of response (DoR)
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Secondary ID(s)
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2013-000087-29-IT
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MO28543
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Source(s) of Monetary Support
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F.Hoffmann-La Roche Ltd.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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