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

NCT01289223 | Terminated Phase 3 DMC

• 2 other identifiers: BDM35022010-022102-41
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Indolent B-cell NHL

Keywords

Indolent B-cell NHL, bendamustine, rituximab, progression-free survival

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Overall Response Rate

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

Study Arms (2)

Treatment of Physicians Choice

ACTIVE COMPARATOR

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: Treatment of Physicians Choice

Bendamustine IV

EXPERIMENTAL

Up to 8 cycles of Bendamustine (120mg/m2 Days 1 and 2, every 21 days (+ 3 days).

Drug: Bendamustine IV

Interventions

Bendamustine IV DRUG

Bendamustine IV

Treatment of Physicians Choice OTHER

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.

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

Treatment of Physicians Choice

Eligibility Criteria

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

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (3)

Princess Alexandra Hospital

Brisbane, Queensland, QLD 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Dr Ludmila Demitrovicova

Bratislava, Slovakia

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 3, 2011
• Study Start: February 1, 2011
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

AU (2); SL (1)