Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
Conditions
Keywords
NHL
Brief summary
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
Detailed description
This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.
Interventions
DRUGVELCADE®
1.6 mg/m\^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
DRUGRituximab
375 mg/m\^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
DRUGCyclophosphamide
400 mg/m\^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
DRUGDecadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Sponsors
Millennium Pharmaceuticals, Inc.
Oncology Specialists, S.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Small Lymphocytic Lymphoma * Follicular Cell Lymphoma (grades I and II) * Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant * Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia * Marginal Zone Lymphoma * MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation. * Adequate bone marrow function, renal function, and hepatic function as outlined in details below. * ECOG performance status of 0, 1, or 2 * Able to read, understand, and sign an IRB approved informed consent
Exclusion criteria
* Known HIV positive status * Known CNS involvement * Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. | 4 years | Percentage of complete responders plus percentage of partial responders equals overall response rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 4 years | The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%. |
Countries
United States
Participant flow
Recruitment details
Rituximab (R) are alone or R based chemo programs are front line approach LG-NHL pts requiring therapy. Identifying programs that are effective in the elderly pts is challenging. These pts were recruited in our private practice.
Pre-assignment details
Eligible pts had LG-NHL requiring treatment. Mantel cell NHL pts who were'nt transplant eligible and MALToma pts who failed RT and antibiotics were allowed.
Participants by arm
| Arm | Count |
|---|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pt had only one cycle. | 1 |
Baseline characteristics
| Characteristic | Velcade, Rituximab,Cyclophosphamide & Decadron |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 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 | 2 / 12 |
Outcome results
Primary
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Percentage of complete responders plus percentage of partial responders equals overall response rate.
Time frame: 4 years
Population: 1 pt withdrew before completing two cycles and was not evaluable for OS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. | 90 percentage of patients |
Secondary
Overall Survival
The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | Overall Survival | 83 percentage of participants |