Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1. |
Drug: Cyclophosphamide
Cyclophosphamide
Other Names:
Drug: Mitoxantrone
Mitoxantrone
Other Names:
Drug: Vincristine
Vincristine
Other Names:
Drug: Prednisone
Prednisone
Drug: Rituximab
Rituximab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
2 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- SCRI Development Innovations, LLC
- Genentech, Inc.
- Amgen
Investigators
- Principal Investigator: John D. Hainsworth, MD, SCRI Development Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SCRI LYM 28
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab |
---|---|
Arm/Group Description | 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 |
Period Title: Induction Chemotherapy | |
STARTED | 51 |
COMPLETED | 48 |
NOT COMPLETED | 3 |
Period Title: Induction Chemotherapy | |
STARTED | 48 |
COMPLETED | 44 |
NOT COMPLETED | 4 |
Baseline Characteristics
Arm/Group Title | CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab |
---|---|
Arm/Group Description | 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 |
Overall Participants | 51 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
78
|
Sex: Female, Male (Count of Participants) | |
Female |
36
70.6%
|
Male |
15
29.4%
|
Region of Enrollment (participants) [Number] | |
United States |
51
100%
|
Outcome Measures
Title | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab |
---|---|
Arm/Group Description | 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 |
Measure Participants | 48 |
Number [percentage of patients] |
81
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | |
Arm/Group Description | 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 | |
All Cause Mortality |
||
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | ||
Affected / at Risk (%) | # Events | |
Total | 24/51 (47.1%) | |
Cardiac disorders | ||
Atrial fibrillation | 3/51 (5.9%) | 3 |
CHF | 1/51 (2%) | 1 |
Ventricular tachycardia | 1/51 (2%) | 1 |
Gastrointestinal disorders | ||
Perforated colon | 1/51 (2%) | 1 |
Fecal incontinence | 1/51 (2%) | 1 |
Gastrointestinal bleed | 1/51 (2%) | 1 |
Diverticulitis | 1/51 (2%) | 1 |
Diverticulosis | 2/51 (3.9%) | 2 |
Intestinal obstruction | 1/51 (2%) | 1 |
Esophagitis | 1/51 (2%) | 1 |
Diarrhea | 1/51 (2%) | 3 |
General disorders | ||
Fever | 1/51 (2%) | 1 |
Infections and infestations | ||
Pneumonia | 2/51 (3.9%) | 2 |
Infection of bilateral heel ulcer wounds | 1/51 (2%) | 1 |
Urinary tract infection | 2/51 (3.9%) | 2 |
Cellulitis | 2/51 (3.9%) | 2 |
Metabolism and nutrition disorders | ||
Tumor lysis syndrome | 1/51 (2%) | 1 |
Hyperglycemia | 1/51 (2%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Infection, L ankle | 1/51 (2%) | 1 |
Fractured hip | 2/51 (3.9%) | 2 |
Fractured ankle | 1/51 (2%) | 1 |
Acute chronic fractures on lumbar spine | 1/51 (2%) | 1 |
Intractable neck pain | 1/51 (2%) | 1 |
Right lower thigh pain | 1/51 (2%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
New primary lung cancer | 1/51 (2%) | 1 |
Nervous system disorders | ||
CVA | 4/51 (7.8%) | 4 |
Concussion, related to fall | 1/51 (2%) | 1 |
Intramedullary spinal cord mass | 1/51 (2%) | 1 |
Renal and urinary disorders | ||
Gross hematuria | 1/51 (2%) | 1 |
Skin and subcutaneous tissue disorders | ||
Acute renal failure | 1/51 (2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab | ||
Affected / at Risk (%) | # Events | |
Total | 51/51 (100%) | |
Blood and lymphatic system disorders | ||
Anemia | 35/51 (68.6%) | 169 |
Leukopenia | 25/51 (49%) | 82 |
Neutropenia | 21/51 (41.2%) | 54 |
Thrombocytopenia | 14/51 (27.5%) | 59 |
Cardiac disorders | ||
Cardiac Toxicity | 8/51 (15.7%) | 17 |
Hypertension | 4/51 (7.8%) | 4 |
Hypotension | 4/51 (7.8%) | 6 |
Gastrointestinal disorders | ||
Anorexia | 29/51 (56.9%) | 85 |
Constipation | 21/51 (41.2%) | 47 |
Diarrhea | 12/51 (23.5%) | 19 |
Mucositis | 5/51 (9.8%) | 8 |
Nausea | 18/51 (35.3%) | 31 |
Stomatitis | 6/51 (11.8%) | 8 |
Taste Alteration | 3/51 (5.9%) | 13 |
Vomiting | 9/51 (17.6%) | 13 |
General disorders | ||
Chills/Rigor | 3/51 (5.9%) | 4 |
Edema | 8/51 (15.7%) | 18 |
Fatigue | 44/51 (86.3%) | 305 |
Fever | 8/51 (15.7%) | 12 |
Insomnia | 6/51 (11.8%) | 8 |
Weakness | 13/51 (25.5%) | 45 |
Infections and infestations | ||
Infection | 19/51 (37.3%) | 36 |
Metabolism and nutrition disorders | ||
Hyperglycemia | 8/51 (15.7%) | 21 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 13/51 (25.5%) | 42 |
Myalgia | 11/51 (21.6%) | 26 |
Nervous system disorders | ||
Dizziness | 8/51 (15.7%) | 11 |
Headache | 3/51 (5.9%) | 4 |
Neuropathy | 4/51 (7.8%) | 6 |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 4/51 (7.8%) | 4 |
Dyspnea | 3/51 (5.9%) | 3 |
Pulmonary | 7/51 (13.7%) | 29 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 30/51 (58.8%) | 152 |
Rash/Skin Irritation | 8/51 (15.7%) | 20 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Name/Title | John D. Hainsworth, MD |
---|---|
Organization | Sarah Cannon Research Institute |
Phone | 615-329-7274 |
jhainsworth@tnonc.com |
- SCRI LYM 28