Lymphoma, Non-Hodgkin
Conditions
Keywords
Lymphoma, Non-Hodgkin, Low-Grade
Brief summary
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
Detailed description
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population. Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
Interventions
DRUGBendamustine
starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w
DRUGBortezomib
weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w
Sponsors
Kantonsspital Aarau
Peter Moosmann
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic recurrent or refractory indolent NHL or B-CLL * Adequate organ and bone marrow function * Karnofsky greater than 50%
Exclusion criteria
* Candidates for autologous stem cell transplantation * Secondary high grade lymphoma * Concurrent severe medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal Bendamustine Dosage for Further Studies | Three weeks after treatment termination |
Participant flow
Recruitment details
Twelve consecutive patients of a medical clinic were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Bortezomib, Bendamustin, combination chemotherapy in nhl | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Optimal Bendamustine Dosage for Further Studies
Time frame: Three weeks after treatment termination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Optimal Bendamustine Dosage for Further Studies | 60 mg/m^2 |