A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia

NCT ID: NCT02071225

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-09
• Study Completion Date: 2018-11-19

Brief Summary

This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL). Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6 months, and participant follow-up will last 2 years.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obinutuzmab + Bendamustine

Participants will receive obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles

Group Type: EXPERIMENTAL

bendamustine

Intervention Type: DRUG

70 milligrams per square meter (mg/m\^2) given by intravenous (IV) infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles.

obinutuzumab

Intervention Type: DRUG

1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.

Interventions

bendamustine

70 milligrams per square meter (mg/m\^2) given by intravenous (IV) infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles.

Intervention Type: DRUG

obinutuzumab

1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.

Intervention Type: DRUG

Other Intervention Names

RO5072759

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Diagnosed CD20+ B- chronic lymphocytic leukemia (CLL) according to National Cancer Institute (NCI) criteria
• Active disease meeting at least 1 of the International Workshop on CLL (IWCLL) 2008 criteria for treatment
• Refractory CLL (i.e. treatment failure or progression during treatment or within 6 months after the last treatment) or relapse CLL (i.e. participants who met criteria for CR or PR, but progressed beyond 6 months post-treatment)
• At least 1 prior purine analogue or bendamustine containing therapy
• Life expectancy greater than (>) 6 months
• Use of effective contraception as described in the study protocol

Exclusion Criteria

• Prior Alogenic Bone Marrow Transplant
• Greater than or equal to (>/=) 3 previous lines of chemotherapy and/or immunotherapy for the CLL
• Previous obinutuzumab-containing regimen
• Treatment failure or progression within 6 months of bendamustine-containing regimen
• Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation) Patients with prolymphocytic transformation cannot entry the study either
• Active haemolytic anaemia
• Inadequate liver function
• History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated but not with curative intent will be excluded, unless the malignancy has been in remission without treatment for >/= 2 years prior to enrolment. Patients with a history of adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent are eligible
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
• Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
• Regular treatment with corticosteroids during the 4 weeks prior to study start, unless administered for another condition at a dose equivalent to less than or equal to (</=) 30 milligrams per day (mg/day) prednisone
• Known active infection or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to study start
• Patients with HIV, human T cell leukemia virus 1 (HTLV-1), hepatitis B or hepatitis C
• Pregnancy or breast-feeding
• Vaccination with a live vaccine within 4 weeks prior to baseline visit
• Receipt of any other study drug within 4 weeks prior to study start

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hospital De Txagorritxu; Servicio de Hematologia

Vitoria-Gasteiz, Alava, Spain

Hospital General Universitario de Elche; Servicio de Hematologia

Elche, Alicante, Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

Badalona, Barcelona, Spain

Hospital Mutua de Terrassa; Servicio de Hematologia

Terrassa, Barcelona, Spain

Hospital General de Castellon; Servicio de Hematologia

Castellon, Castellon, Spain

Hospital de Navarra, Servicio de Hematología

Pamplona, Navarre, Spain

Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

Gijón, Principality of Asturias, Spain

Hospital Univ. Central de Asturias; servicio de Hematologia

Oviedo, Principality of Asturias, Spain

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Universitari Vall d'Hebron; Servicio de Hematologia

Barcelona, , Spain

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, , Spain

Hospital Universitario Virgen de las Nieves; Servicio de Hematologia

Granada, , Spain

Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia

Las Palmas, , Spain

Hospital Universitario la Paz; Servicio de Hematologia

Madrid, , Spain

Hospital Universitario Puerta de Hierro; Servicio de Hematologia

Madrid, , Spain

Hospital Costa del Sol; Servicio de Hematologia

Málaga, , Spain

Hospital Universitario Virgen Macarena; Servicio de Hematologia

Seville, , Spain

Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia

Seville, , Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Hospital Universitario Dr. Peset; Servicio de Hematologia

Valencia, , Spain

Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

Zaragoza, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013-003388-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML29167

Identifier Type: -

Identifier Source: org_study_id