International study evaluating safety of Obinutuzumab alone or in combination with chemotherapy in patients with Chronic Lymphocytic Leukemia.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2013-000087-29-ES
• Date of registration: 12/07/2013
• Prospective Registration: Yes
• Primary sponsor: Roche Farma, S.A. , en nombre de F. Hoffmann- La Roche Ltd.
• Public title: International study evaluating safety of Obinutuzumab alone or in combination with chemotherapy in patients 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: 12/02/2014
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000087-29
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

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 530
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

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), history of HIV seropositive status, 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

Health Condition(s) or Problem(s) studied

Chronic lymphocytic leukemia
MedDRA version: 16.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864
MedDRA version: 16.1 Level: LLT Classification code 10008977 Term: Chronic lymphocytic leukemia recurrent System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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-

Primary Outcome(s)

Main Objective: ? To evaluate the safety and tolerability of obinutuzumab alone or in combination with chemotherapy

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

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 at the end of treatment (at the final response assessment)
- Overall response rate (ORR) at the end of treatment
- 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)

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.

Secondary Outcome(s)

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 at the end of treatment
- Overall response rate (ORR) at the end of treatment
- 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)

Timepoint(s) of evaluation of this end point: Assessed at: screening, day 57 during treatment, 169 then 225 and every 3 months until the end of study.

Secondary ID(s)

2013-000087-29-IT

MO28543

Source(s) of Monetary Support

F.Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 06/01/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000087-29/results