Chronic Lymphocytic Leukemia, Indolent Non-Hodgkin's Lymphoma
Conditions
Keywords
iNHL, CLL
Brief summary
The purpose of the current study is to evaluate additional safety data of bendamustine in up to 100 patients with Indolent Non-Hodgkin's Lymphoma (iNHL) relapsing from a rituximab regimen or Chronic Lymphocytic Leukemia (CLL). Patients will receive up to 6 or 8 cycles of bendamustine treatment using the dosing regimens of TREANDA® (bendamustine) approved in several countries, which have been shown to be reasonably well tolerated. The study protocol includes safety monitoring (i.e., adverse events, concomitant medications, supportive care, clinical safety laboratory tests, and clinical disease status monitoring). It is an interventional, multicentre, prospective, open-label expanded access study, which in addition allows investigators in Canada, and their patients, access to bendamustine while it is pending Canadian marketing approval. Although the treatment options available for patients with iNHL or CLL do induce substantial responses, there is no curative treatment. One potential drug candidate for the treatment of CLL and iNHL is bendamustine. Bendamustine has been widely used in Germany for more than 30 years and is marketed in the United States for treatment of CLL and for treatment of iNHL that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. In October 2010, the European Medicines Agency formally approved bendamustine in a number of Member States of the European Union for the treatment of patients with iNHL, CLL, and multiple myeloma. The drug's safety profile in these patient populations has been extensively characterized and no unexpected safety concerns are anticipated.
Interventions
DRUGBendamustine at a dose of 100 mg/m2
Bendamustine will be administered intravenously over 30 minutes.
DRUGBendamustine at a dose of 120 mg/m2
Bendamustine will be administered intravenous (i.v.) over 60 minutes.
Sponsors
Lundbeck Canada Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for iNHL: * The patient has biopsy-confirmed diagnosis of indolent B-cell NHL documented as relapsed or refractory iNHL (following rituximab-based therapy). * The patient has one of the following types of indolent B-cell lymphoma: * follicular lymphoma grade 1, 2, or 3A * marginal zone lymphoma * lymphoplasmacytic lymphoma * small lymphocytic lymphoma * The patient has adequate haematologic function (unless abnormalities are related to lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma). Inclusion Criteria for CLL: * The patient has previously confirmed (according to WHO criteria) untreated symptomatic chronic B-cell lymphocytic leukemia Binet Stage B or Binet Stage C or Rai stage II to IV in need of medical treatment. * The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion criteria
* The patient has participated in a clinical study \<30 days prior to the Screening Visit. * The patient has one or more of the following conditions: * active transformed lymphoma * any history of central nervous system or leptomeningeal lymphoma * an active malignancy other than the target cancer within the past 5 years * human immunodeficiency virus * The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | Up to 266 days |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Previously Untreated CLL Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes. | 16 |
| Patients With iNHL Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes. | 74 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 17 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Disease Progression | 2 | 10 |
| Overall Study | Investigator Discretion | 3 | 8 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other Reasons | 2 | 5 |
| Overall Study | Withdrawal of Consent | 0 | 1 |
Baseline characteristics
| Characteristic | Patients With Previously Untreated CLL | Patients With iNHL | Total |
|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 7.12 | 63.1 years STANDARD_DEVIATION 10.84 | 64.2 years STANDARD_DEVIATION 10.51 |
| Sex: Female, Male Female | 9 Participants | 35 Participants | 44 Participants |
| Sex: Female, Male Male | 7 Participants | 39 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 16 | 72 / 74 |
| serious Total, serious adverse events | 6 / 16 | 27 / 74 |
Outcome results
Primary
Number of Adverse Events
Time frame: Up to 266 days
Population: APTS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Previously Untreated CLL | Number of Adverse Events | 298 number of adverse events |
| Patients With iNHL | Number of Adverse Events | 302 number of adverse events |