Mantle Cell Lymphoma
Conditions
Keywords
Untreated Mantle Cell Lymphoma
Brief summary
Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
Detailed description
Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
Interventions
DRUGBortezomib
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
DRUGRituximab
Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
DRUGCyclophosphamide
Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
DRUGDoxorubicin
Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
DRUGVincristine
1 mg administered by IV on day 3 of each cycle.
DRUGDexamethasone
40 mg orally on days 1-4 of each cycle.
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
* Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.
Exclusion criteria
* Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). | At completion of induction therapy (21 weeks) | Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses. |
| Complete Response Rate (CR) at the End of Induction Chemotherapy | at 21 weeks | Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3 Year Progression Free Survival | 36 months | This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study. |
| 3 Year Overall Survival (OS) | 36 months | This is the percent of participants who were still alive at 3 years after study entry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VCR-CVAD With Rituximab Maintenance | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression or no response | 3 |
Baseline characteristics
| Characteristic | VCR-CVAD With Rituximab Maintenance |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 26 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 18 / 30 |
Outcome results
Primary
Complete Response Rate (CR) at the End of Induction Chemotherapy
Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.
Time frame: at 21 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCR-CVAD With Rituximab Maintenance | Complete Response Rate (CR) at the End of Induction Chemotherapy | 77 percent of participants |
Primary
Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).
Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses.
Time frame: At completion of induction therapy (21 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCR-CVAD With Rituximab Maintenance | Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). | 90 Percent of participants |
Secondary
3 Year Overall Survival (OS)
This is the percent of participants who were still alive at 3 years after study entry.
Time frame: 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCR-CVAD With Rituximab Maintenance | 3 Year Overall Survival (OS) | 86 Percent of participants |
Secondary
3 Year Progression Free Survival
This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.
Time frame: 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCR-CVAD With Rituximab Maintenance | 3 Year Progression Free Survival | 63 percent of participants |