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Indolent B-cell NHLPhase 3ROBINNCT01289223

A Trial to Investigate the Efficacy of Bendamustine in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Refractory to Rituximab.

A Phase 3 study testing Bendamustine IV and Treatment of Physicians Choice in people with Indolent B-cell NHL, run by Mundipharma Research Limited at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To compare the efficacy of bendamustine against treatment of physician's choice on progression-free survival in subjects with indolent B-cell NHL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Indolent B-cell NHL
What is being tested?
Bendamustine IV and Treatment of Physicians Choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
3 sitesin 2 countries
Study dates
Feb 2011to 31 Jul 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 34Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Princess Alexandra Hospital

    Brisbane, Queensland, QLD 4102

Other trials in Australia

Slovakia1 site

  • Dr Ludmila Demitrovicova

    Bratislava

Other trials in Slovakia

About this study

Official title: 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.

Read the 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.

Being tested
Bendamustine IV, Treatment of Physicians Choice
Keywords
Indolent B-cell NHL, bendamustine, rituximab, progression-free survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bendamustine IVDrug

  • Treatment of Physicians ChoiceOther

    Also called Defined as any cancer specific therapy or best supportive care.

    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.

Study groups in NCT01289223
Study groupRoleWhat they receive
Treatment of Physicians ChoiceActive comparatorDefined 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.
Receives: Other: Treatment of Physicians Choice
Bendamustine IVExperimentalUp to 8 cycles of Bendamustine (120mg/m2 Days 1 and 2, every 21 days (+ 3 days).
Receives: Drug: Bendamustine IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    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.

    Measured: 8 cycles of 21 days, then follow up every 3 months

Secondary outcomes (1)

  1. Overall Response Rate

    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

    Measured: 8 cycles of 21 days, then follow up every 3 months until progressive disease, then every 6 months for overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Why it stopped: Ongoing challenges to successfully recruit the required number of subjects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01289223
Sponsor's protocol ID
BDM3502
Other IDs
2010-022102-41
Acronym
ROBIN
Status last verified
Aug 2018
First submitted
2 Feb 2011
Last updated
4 Sep 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bendamustine IV and Treatment of Physicians Choice in people with Indolent B-cell NHL, run by Mundipharma Research Limited at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Ongoing challenges to successfully recruit the required number of subjects). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 8 cycles of 21 days, then follow up every 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01289223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.

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