Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatments bendamustine, obinutuzumab
Phase phase 2
Target CD20
Sponsor Hoffmann-La Roche
Start date April 2014
End date October 2018
Trial size 72 participants
Trial identifier NCT02071225, 2013-003388-79, ML29167

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive obintuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles
bendamustine
70 milligrams per square meter (mg/m^2) given by IV infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles.
obinutuzumab
1000 mg given by intravenous (IV) infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.

Primary Outcomes

Measure
Percentage of participants acheiving Overall Response as assessed by the investigator using the IWCLL 2008 criteria
time frame: 2-3 months after last dose of the study treatment (up to 9 months overall)

Secondary Outcomes

Measure
Percentage of participants acheiving Best response up to 6 months after treatment assessed by the investigator using the IWCLL 2008 criteria.
time frame: Approximately 6 months after treatment (up to 12 months overall)
Duration of progression free survival (PFS) assessed using the IWCLL 2008 criteria
time frame: From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 2.5 years after last patient first visit [LPFV] overall)
Duration of overall survival (OS)
time frame: Baseline up to death (up to approximately 2.5 years after LPFV overall)
Duration of event free survival (EFS) assessed using the IWCLL 2008 criteria
time frame: 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 2.5 years after LPFV overall)
Duration of disease free survival (DFS) assessed using the IWCLL 2008 criteria
time frame: From occurrence of CR up to disease progression or death, whichever occurred first (up to approximately 2.5 years after LPFV overall)
Duration of Response (DR) assessed using the IWCLL 2008 criteria
time frame: From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 2.5 years after LPFV overall)
Time from study start to re-treatment or new therapy
time frame: Up to 2.5 years
Percentage of participants without minimal residual disease (MRD-negative), as assessed by flow cytometry
time frame: Approximately 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 trhan or equal to (

Additional Information

Official title Phase II Trial to Evaluate The Efficacy of Obinutuzumab (RO5072759) + Bendamustine Treatment in Patients With Refractory Or Relapsed Chronic Lymphocytic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.