Mantle Cell Lymphoma
Conditions
Keywords
untreated mantle cell lymphoma
Brief summary
rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
Detailed description
rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
Interventions
DRUGmodified Hyper-CVAD
rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
Sponsors
University of Wisconsin, Madison
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
* Untreated mantle cell lymphoma
Exclusion criteria
* Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate to Induction Therapy | Median follow up of 37 months | Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 SAEs during induction therapy | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 8 / 22 |
Outcome results
Primary
Complete Response Rate to Induction Therapy
Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).
Time frame: Median follow up of 37 months
Population: All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Complete Response Rate to Induction Therapy | 64 percentage of participants |