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

Roche

Status and phase

Completed

Phase 2

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: obinutuzumab

Drug: bendamustine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02071225

ML29167

2013-003388-79 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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