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Trial record 101 of 317 for:    BENDAMUSTINE

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

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ClinicalTrials.gov Identifier: NCT02071225
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: bendamustine Drug: obinutuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial to Evaluate The Efficacy of Obinutuzumab (RO5072759) + Bendamustine Treatment in Patients With Refractory Or Relapsed Chronic Lymphocytic Leukemia
Actual Study Start Date : April 9, 2014
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018


Arm Intervention/treatment
Experimental: obinutuzmab + bendamustine
Participants will receive obintuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles
Drug: 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.

Drug: 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 Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Duration of overall survival (OS) [ Time Frame: Baseline up to death (up to approximately 2.5 years after LPFV overall) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. Time from study start to re-treatment or new therapy [ Time Frame: Up to 2.5 years ]
  8. Percentage of participants without minimal residual disease (MRD-negative), as assessed by flow cytometry [ Time Frame: Approximately 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 trhan 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071225


Locations
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Spain
Hospital De Txagorritxu; Servicio de Hematologia
Vitoria, Alava, Spain, 01009
Hospital General Universitario de Elche; Servicio de Hematologia
Elche, Alicante, Spain, 03203
Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
Gijon, Asturias, Spain, 33203
Hospital Univ. Central de Asturias; servicio de Hematologia
Oviedo, Asturias, Spain, 33011
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona, Spain, 08915
Hospital Mutua de Terrassa; Servicio de Hematologia
Terrassa, Barcelona, Spain, 08221
Hospital de Navarra, Servicio de Hematología
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Hospital de Basurto; Servicio de Hematologia
Bilbao, Vizcaya, Spain, 48013
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital General de Castellon; Servicio de Hematologia
Castellon, Spain, 12004
Hospital Universitario Reina Sofia; Servicio de Hematologia
Cordoba, Spain, 14004
Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
Granada, Spain, 18014
Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia
Las Palmas, Spain, 35020
Fundacion Jimenez Diaz; Servicio de Hematologia
Madrid, Spain, 28040
Hospital Universitario la Paz; Servicio de Hematologia
Madrid, Spain, 28046
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro; Servicio de Hematologia
Madrid, Spain, 28222
Hospital Costa del Sol; Servicio de Hematologia
Malaga, Spain, 29600
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
Orense, Spain, 32005
Hospital Universitario Virgen Macarena; Servicio de Hematologia
Sevilla, Spain, 41009
Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia
Sevilla, Spain, 41014
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Hospital Universitario Dr. Peset; Servicio de Hematologia
Valencia, Spain, 46017
Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02071225     History of Changes
Other Study ID Numbers: ML29167
2013-003388-79 ( EudraCT Number )
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Obinutuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological