Clinical trial NCT02071225: A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
Official title: Phase II Trial to Evaluate The Efficacy of Obinutuzumab (RO5072759) + Bendamustine Treatment in Patients With Refractory Or Relapsed Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
timeFrame: 2-3 months after last dose of the study treatment (up to approximately 9 months)
Secondary outcomes:
measure: Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria
timeFrame: During study treatment and until 6 months after end of study treatment at approximately 12 months
measure: Progression Free Survival (PFS)
timeFrame: From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years)
measure: Overall Survival (OS)
timeFrame: From start of treatment up to death of any cause (up to approximately 4.5 years)
measure: Event Free Survival (EFS)
timeFrame: From start of treatment up to disease progression or relapse or death or start of a new anti-leukemic therapy, whichever occurred first (up to approximately 4.5 years)
measure: Disease Free Survival (DFS)
timeFrame: From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years)
measure: Duration of Response (DR)
timeFrame: From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years)
measure: Time to Re-treatment/New Anti-leukemia Therapy
timeFrame: Up to 4.5 years
measure: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
timeFrame: At approximately 9 months
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to approximately 4.5 years
measure: Percentage of Participants With AEs of Special Interest (AESIs)
timeFrame: Up to approximately 4.5 years
measure: Percentage of Participants With Infusion-related Reactions (IRRs)
timeFrame: Up to end of treatment at 6 months
measure: Percentage of Participants Who Discontinued Treatment Prematurely
timeFrame: Up to end of treatment at 6 months
measure: Percentage of Participants With Previous/Concomitant Diseases
timeFrame: Up to approximately 4.5 years
measure: Percentage of Participants With Concomitant Medication
timeFrame: From 7 days prior to screening to the end of treatment at 6 months
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital De Txagorritxu; Servicio de Hematologia
state: Alava
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Hematologia
state: Alicante
city: Gijon
country: Spain
facility: Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; servicio de Hematologia
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa; Servicio de Hematologia
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital de Navarra, Servicio de Hematología
state: Navarra
city: Santa Cruz de Tenerife
country: Spain
facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Castellon
country: Spain
facility: Hospital General de Castellon; Servicio de Hematologia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
city: Las Palmas
country: Spain
facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario la Paz; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Hematologia
city: Malaga
country: Spain
facility: Hospital Costa del Sol; Servicio de Hematologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Hematologia
city: Sevilla
country: Spain
facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset; Servicio de Hematologia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: