- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289223
A Trial to Investigate the Efficacy of Bendamustine in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Refractory to Rituximab. (ROBIN)
August 30, 2018 updated by: Mundipharma Research Limited
A Randomised, Open Label, Multi-centre, Phase III Study to Investigate the Efficacy of Bendamustine Compared to Treatment of Physician's Choice in the Treatment of Subjects With Indolent Non-Hodgkin's Lymphoma (NHL) Refractory to Rituximab
To compare the efficacy of bendamustine against treatment of physician's choice on progression-free survival in subjects with indolent B-cell NHL.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
To test whether bendamustine will improve progression-free survival in subjects with indolent B-cell NHL that did not respond (stable disease or progressive disease) to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment compared to treatment of physican's choice.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Indolent B-cell lymphoma: grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass > 5 cm in any direction) defined according to WHO Classification, 2008
- CT imaging in screening phase (based on local evaluation) showing 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or 1 clearly demarcated lesion with a largest diameter ≥ 2.0 cm. CT imaging performed at screening will be considered the baseline image
Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen:
- Maintaining stable disease or failure to achieve PR to rituximab-based therapy. (CT imaging will support this finding, and will be performed at least 30 days after the last dose of rituximab-based therapy) or,
- Disease progression while on rituximab-based therapy (e.g., includes 4 weekly courses of rituximab given at 6 week intervals) or,
- Disease progression in subjects with stable disease or better response to rituximab-based therapy < 6 months of the last dose of rituximab Note: Subjects must have received at least 4 infusions of rituximab (either as monotherapy or in combination with any chemotherapy).
Screening laboratory values:
- Platelets ≥ 75,000/µL (7 x 109 cells/L)
- Absolute neutrophil count (ANC) ≥ 1,000/µL (1.0 x 109 cells/L)
- ALT, AST and alkaline phosphatase ≤ 2.5 ULN and total bilirubin ≤ 1.5 xULN (isolated predominantly indirect hyperbilirubinaemia due to Gilbert's syndrome is acceptable for inclusion)
- ECOG Performance Status of 0, 1, or 2
- Age ≥ 18 years
- Life expectancy of at least 3 months
- Signed written informed consent prior to performing any study-specific procedures
Main exclusion criteria:
- Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma as verified by biopsy confirmation [e.g. constitutional symptoms, poor performance status, fast growing tumour or increasing lactate dehydrogenase (LDH) level]
- Previous allogeneic stem cell transplant
- Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla or to more than 3 vertebral bodies
- More than 10 mg prednisolone daily at the time of randomisation
- Prior bendamustine treatment within 1 year of randomisation not resulting in a CR or PR for at least 6 months
- Known CNS involvement of indolent lymphoma
- Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months of screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extrasystoles or minor conduction abnormalities. Subjects with well controlled congestive heart failure and atrial arrhythmias need not be excluded but should be discussed with the study Medical Monitor
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- History of significant cerebrovascular disease or event with significant symptoms or sequelae
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment)
- Jaundice
- Known HIV, Hepatitis B or Hepatitis C positive
- Creatinine clearance ≤ 10 mL/min (measured or estimated using Cockcroft and Gault equation)
- Treatment with any known non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks prior to screening, whichever is longer or currently participating in any other interventional clinical study unless the sole purpose of the study is for collection of survival data
- Known or suspected inability to comply with study protocol
- Lactating women, women with a positive pregnancy test at screening or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through last treatment dose and for 6 months following cessation of treatment. Female contraception must be individually recommended by an expert. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS), male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject, or double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
20.Major surgery less than 30 days prior to start of treatment. 21.Known hypersensitivity to the active substance or any excipients that cannot be controlled by appropriate pre-medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment of Physicians Choice
Defined as any cancer specific therapy or best supportive care.
Treatment should be given according to the label and based upon local institutional medical practice and clinical judgement.
|
Defined as any cancer specific therapy or best supportive care.
Treatment should be given according to the label and based upon local institutional medical practice and clinical judgement.
Other Names:
|
Experimental: Bendamustine IV
Up to 8 cycles of Bendamustine (120mg/m2 Days 1 and 2, every 21 days (+ 3 days).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 8 cycles of 21 days, then follow up every 3 months
|
Screening of 14 days, prior to ramdomisation.
8 cycles of 21 days, then follow up every 3 months after end of last cycle until disease progression, then every 6 months.
|
8 cycles of 21 days, then follow up every 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: 8 cycles of 21 days, then follow up every 3 months until progressive disease, then every 6 months for overall survival
|
Complete remission (CR)/partial remission (PR), Duration of response (DR), Overall survival (OS), Safety and tolerability, Change in health related quality of life (HRQL) measures
|
8 cycles of 21 days, then follow up every 3 months until progressive disease, then every 6 months for overall survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
February 2, 2011
First Submitted That Met QC Criteria
February 2, 2011
First Posted (Estimate)
February 3, 2011
Study Record Updates
Last Update Posted (Actual)
September 4, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Bendamustine Hydrochloride
Other Study ID Numbers
- BDM3502
- 2010-022102-41 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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