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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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23 November 2020 |
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Main ID: |
EUCTR2009-015504-25-IT |
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Date of registration:
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10/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximabrefractory, indolent Non-Hodgkin’s Lymphoma. - ND
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Scientific title:
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An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + RO5072759 (GA101) in patients with Rituximabrefractory, indolent Non-Hodgkin’s Lymphoma. - ND |
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Date of first enrolment:
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20/06/2010 |
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Target sample size:
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360 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015504-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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France
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients must meet the following inclusion criteria to be eligible for study entry: • History of histologically documented, CD20+, indolent NHL (including follicular lymphoma, grades 1-3a; marginal zone lymphoma [including splenic, nodal, and extra-nodal]; and small lymphocytic lymphoma with an absolute lymphocyte count < 5000). For each patient, a prior biopsy demonstrating CD20 positivity of tumor cells must be available locally at the investigator site prior to dosing; this will be further confirmed retrospectively following central pathology review. A lymph node biopsy to rule out transformation is required in patients for whom there is clinical suspicion of transformation. • Refractory to a regimen containing rituximab, defined as no response to, or progression within 6 months of completion of, the last dose of rituximab therapy (either as monotherapy or in combination with chemotherapy), including: Patients with progressive disease while receiving rituximab monotherapy, rituximab + chemotherapy, or rituximab maintenance therapy, after having received at least one full dose (375 mg/m2) of rituximab Patients with no clinical response (PR or better) to a rituximab-containing regimen consisting of at least 4 weekly doses of rituximab monotherapy or at least 4 cycles of rituximab + chemotherapy Patients with disease relapse (after having achieved a clinical response) within 6 months of completion of the last dose of rituximab therapy in a regimen consisting of at least 4 weekly doses of rituximab monotherapy or at least 4 cycles of rituximab + chemotherapy • Previously treated with a maximum of three unique chemotherapy containing treatment regimens (“unique treatment regimen” is defined as at least two cycles of treatment of a planned multi-dose regimen containing chemotherapy with or without antibody-based therapy). Prior autologous stem cell transplant or radioimmunotherapy is permitted if it is completed more than 6 months prior to study entry. • All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan). Tumor response will be based on the status of all areas of disease and assessed according to the modified response criteria for NHL (Cheson et al. 2007; see Appendix E). • Able and willing to provide written informed consent and to comply with the study protocol. • Age >= 18 years. • ECOG performance status of 0, 1, or 2 (see Appendix D).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
The following will exclude patients from study entry: • Prior use of any monoclonal antibody (other than anti-CD20) within 3 months of the start of Cycle 1 • Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1 • Prior treatment with bendamustine within 1 year of the start of Cycle 1 Patients with prior bendamustine treatment (i.e., greater than 1 year prior to the start of Cycle 1) must have achieved either a partial or complete response to the bendamustine regimen of at least 6 months in duration prior to relapse/progression in order to be eligible • Prior allogeneic stem cell transplant • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom re-dosing with rituximab would be contraindicated for safety reasons) • History of sensitivity to mannitol • Central nervous system lymphoma or histological evidence of transformation to high grade or diffuse large B-cell lymphoma • History of other malignancy that could affect compliance with the protocol or interpretation of results Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for >= 2 years prior to enrollment. • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks of the start of Cycle 1 • Vaccination with a live vaccine a minimum of 28 days prior to randomization • Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis • Any of the following abnormal laboratory values: Creatinine > 1.5 times the upper limit of normal (unless creatinine clearance normal), or creatinine clearance < 40 mL/min Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal Total bilirubin =3 x ULN Platelet count < 75 x 10^9/L (unless due to underlying disease, as established by extensive bone marrow involvement) For patients with autologous prior stem cell transplant, platelet count < 100 x 10^9/L (unless due to underlying disease as established by extensive bone marrow involvement). Neutrophil count < 1.5 x 10^9/L (unless due to underlying disease, as established by extensive bone marrow involvement) Hemoglobin <10g/dL (unless due to underlying disease, as established by extensive bone marrow involvement) Et al.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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CD20+, indolent NHL
MedDRA version: 12.1
Level: LLT
Classification code 10029547
Term: Non-Hodgkin's lymphoma
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Intervention(s)
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Product Name: GA101
Product Code: Ro 507-2759/F06
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 949142-50-1
Current Sponsor code: RO5072759
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Product Name: GA101
Product Code: Ro 507-2759/F05
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 949142-50-1
Current Sponsor code: RO5072759
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Ribomustin
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Bendamustine hydrochloride
CAS Number: 3543-75-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Ribomustin
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Bendamustine hydrochloride
CAS Number: 3543-75-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
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Primary Outcome(s)
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Main Objective: The primary objective for this study is as follows: • To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used in combination with bendamustine compared with bendamustine alone in patients with indolent NHL refractory to prior rituximab-containing therapy.
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Primary end point(s): Progression-free survival is defined as the time from randomization to the first occurrence of progression or relapse as assessed by the IRF, or death from any cause.
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Secondary Objective: The secondary objectives for this study are as follows: • To compare OS between study arms • To evaluate in each study arm and compare between study arms the following: overall response rate (ORR = rate of complete response [CR] + partial response [PR]) and CRR after the end of 6 months of treatment; best ORR achieved during treatment or within 12 months of the start of treatment; disease-free survival in CR patients; and duration of response in patients with CR and PR • To compare event-free survival (EFS) between the two study arms • To evaluate and compare the safety profiles of patients treated with the combination of GA101 + bendamustine and bendamustine alone. • To characterize the pharmacokinetics of GA101 in combination with bendamustine and evaluate for drug-drug interactions by comparing the pharmacokinetics of the combination with the pharmacokinetics of bendamustine alone Et al.
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Secondary ID(s)
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GAO4753g
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2009-015504-25-CZ
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/05/2010
Contact:
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