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

NCT02071225 | Completed Phase 2 Results

• 2 other identifiers: ML291672013-003388-79
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 21

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria

  ORR was defined as percentage of participants achieving Complete Response (CR), incomplete CR (CRi) or Partial Response (PR). CR: lymphocytes below 4 x 10\^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 110 g/L or increase ≥ 50% compared to pre-treatment.

  2-3 months after last dose of the study treatment (up to approximately 9 months)

Secondary Outcomes (14)

• Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria

  During study treatment and until 6 months after end of study treatment at approximately 12 months

• Progression Free Survival (PFS)

  From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years)

• Overall Survival (OS)

  From start of treatment up to death of any cause (up to approximately 4.5 years)

• Event Free Survival (EFS)

  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)

• Disease Free Survival (DFS)

  From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years)

Study Arms (1)

Obinutuzmab + Bendamustine

EXPERIMENTAL

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

Drug: bendamustine; Drug: obinutuzumab

Interventions

bendamustine 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.

Obinutuzmab + Bendamustine

obinutuzumab DRUG

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

Also known as: RO5072759

Obinutuzmab + Bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (21)

Hospital De Txagorritxu; Servicio de Hematologia

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Hospital General Universitario de Elche; Servicio de Hematologia

Elche, Alicante, 03203, Spain

Location

Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

Badalona, Barcelona, 08915, Spain

Location

Hospital Mutua de Terrassa; Servicio de Hematologia

Terrassa, Barcelona, 08221, Spain

Location

Hospital General de Castellon; Servicio de Hematologia

Castellon, Castellon, 12004, Spain

Location

Hospital de Navarra, Servicio de Hematología

Pamplona, Navarre, 31008, Spain

Location

Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

Gijón, Principality of Asturias, 33203, Spain

Location

Hospital Univ. Central de Asturias; servicio de Hematologia

Oviedo, Principality of Asturias, 33011, Spain

Location

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia

Santa Cruz de Tenerife, Tenerife, 38010, Spain

Location

Hospital Universitari Vall d'Hebron; Servicio de Hematologia

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de las Nieves; Servicio de Hematologia

Granada, 18014, Spain

Location

Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia

Las Palmas, 35020, Spain

Location

Hospital Universitario la Paz; Servicio de Hematologia

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro; Servicio de Hematologia

Madrid, 28222, Spain

Location

Hospital Costa del Sol; Servicio de Hematologia

Málaga, 29600, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Hematologia

Seville, 41009, Spain

Location

Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia

Seville, 41014, Spain

Location

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, 46010, Spain

Location

Hospital Universitario Dr. Peset; Servicio de Hematologia

Valencia, 46017, Spain

Location

Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; obinutuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: April 9, 2014
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: February 7, 2020
• Results First Posted: November 26, 2019

Record last verified: 2020-02

Locations

ES (21)