Non-Hodgkins Lymphoma
Conditions
Brief summary
The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.
Detailed description
Upon determination of eligibility, patients will receive: * Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.
Interventions
DRUGCyclophosphamide
Cyclophosphamide
DRUGMitoxantrone
Mitoxantrone
DRUGVincristine
Vincristine
DRUGPrednisone
Prednisone
DRUGRituximab
Rituximab
Sponsors
Genentech, Inc.
Amgen
SCRI Development Innovations, LLC
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
To be included in this study, you must meet the following criteria: * Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma * No previous treatment * Clinical stage II, III, or IV by the Ann Arbor Staging Criteria * Age \> 70 years * ECOG performance status 0, 1, or 2 * Adequate bone marrow, liver and kidney function * Must give written informed consent prior to entering this trial
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Age \< 18 years * Central nervous system involvement with lymphoma * Coexistent active malignancies treated within five years * Active infection precluding the use of combination chemotherapy * HIV infection * Pregnant or lactating Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 18 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Countries
United States
Participant flow
Pre-assignment details
Forty-eight of 51 patients (94%) completed the initial three courses of rituximab/chemotherapy. Forty-four of the 48 patients (92%) received the Rituximab maintenance therapy.
Participants by arm
| Arm | Count |
|---|---|
| CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Induction Chemotherapy | Adverse Event | 2 |
| Induction Chemotherapy | Disease Progression | 1 |
| Maintenance Rituximab | Opted for full course rituximab/chemotherapy | 2 |
| Maintenance Rituximab | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab |
|---|---|
| Age, Continuous | 78 years |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 51 |
| serious Total, serious adverse events | 24 / 51 |
Outcome results
Primary
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 18 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 81 percentage of patients |