VRCD: VELCADE,Rituximab,Cyclophosphamide and Decadron
Study Details
Study Description
Brief Summary
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: VELCADE®
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
Other Names:
Drug: Rituximab
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.
Other Names:
Drug: Cyclophosphamide
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Other Names:
Drug: Decadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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%.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Onocology Specialists, S.C | Niles | Illinois | United States | 60714 |
| 2 | Oncology Specialists, S.C | Park Ridge | Illinois | United States | 60068 |
Sponsors and Collaborators
- Oncology Specialists, S.C.
- Millennium Pharmaceuticals, Inc.
Investigators
- Principal Investigator: Chadi Nabhan, MD, Oncology Specialists, SC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0606
Study Results
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 Detail | 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. |
| Arm/Group Title | Velcade, Rituximab,Cyclophosphamide & Decadron |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 12 |
| COMPLETED | 11 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Velcade, Rituximab,Cyclophosphamide & Decadron |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 12 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
1
8.3%
|
| >=65 years |
11
91.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
33.3%
|
| Male |
8
66.7%
|
| Region of Enrollment (participants) [Number] | |
| United States |
12
100%
|
Outcome Measures
| Title | Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. |
|---|---|
| Description | Percentage of complete responders plus percentage of partial responders equals overall response rate. |
| Time Frame | 4 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 1 pt withdrew before completing two cycles and was not evaluable for OS. |
| Arm/Group Title | Velcade, Rituximab,Cyclophosphamide & Decadron |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 11 |
| Number [percentage of patients] |
90
|
| Title | Overall Survival |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Velcade, Rituximab,Cyclophosphamide & Decadron |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 11 |
| Number [percentage of participants] |
83
691.7%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Velcade, Rituximab,Cyclophosphamide & Decadron | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Velcade, Rituximab,Cyclophosphamide & Decadron | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Velcade, Rituximab,Cyclophosphamide & Decadron | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/12 (16.7%) | |
| Cardiac disorders | ||
| Congestive Heart Failure | 1/12 (8.3%) | |
| Nervous system disorders | ||
| Cerebral Vascular Accident | 1/12 (8.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Velcade, Rituximab,Cyclophosphamide & Decadron | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/12 (100%) | |
| Blood and lymphatic system disorders | ||
| Leukopenia Grade 1 & 2 | 2/12 (16.7%) | |
| Tronopin Increased Grade 1 & 2 | 1/12 (8.3%) | |
| Leukopenia Grade 3 & 4 | 3/12 (25%) | |
| Neutropenia Grade 3 & 4 | 3/12 (25%) | |
| Cardiac disorders | ||
| Hypertension Grade 1 & 2 | 1/12 (8.3%) | |
| Gastrointestinal disorders | ||
| Abdominal Pain Grade 1 & 2 | 1/12 (8.3%) | |
| Appetite Decreased Grade 1 & 2 | 1/12 (8.3%) | |
| Constipation Grade 1 & 2 | 1/12 (8.3%) | |
| Hyponatremia Grade 1 & 2 | 1/12 (8.3%) | |
| Hyperglycemia Grade 1 & 2 | 2/12 (16.7%) | |
| Nausea Grade 1 & 2 | 3/12 (25%) | |
| Mucositis Grade 1 & 2 | 1/12 (8.3%) | |
| Stomatitis Grade 1 & 2 | 1/12 (8.3%) | |
| Weight Decreased Grade 1 & 2 | 2/12 (16.7%) | |
| Vomiting Grade 1 & 2 | 1/12 (8.3%) | |
| Hyperglycemia Grade 3 & 4 | 1/12 (8.3%) | |
| General disorders | ||
| Anxiety Grade 1 & 2 | 2/12 (16.7%) | |
| Alopecia Grade 1 & 2 | 1/12 (8.3%) | |
| Chills Grade 1 & 2 | 2/12 (16.7%) | |
| Edema Grade 1 & 2 | 2/12 (16.7%) | |
| Fever Grade 1 & 2 | 1/12 (8.3%) | |
| Fatigue Grade 1 & 2 | 4/12 (33.3%) | |
| Insomnia Grade 1 & 2 | 1/12 (8.3%) | |
| Sweats Grade 1 & 2 | 2/12 (16.7%) | |
| Triglyceride Increased Grade 1 & 2 | 1/12 (8.3%) | |
| Tongue Swelling Grade 1 & 2 | 1/12 (8.3%) | |
| Tooth Abcess Grade 1 & 2 | 1/12 (8.3%) | |
| Headache Grade 1 & 2 | 1/12 (8.3%) | |
| Pain Grade 1 & 2 | 2/12 (16.7%) | |
| Musculoskeletal and connective tissue disorders | ||
| Difficulty Walking Grade 1 & 2 | 2/12 (16.7%) | |
| Chest Pain Grade 3 & 4 | 1/12 (8.3%) | |
| Renal and urinary disorders | ||
| Bilirubin Increased Grade 1 & 2 | 1/12 (8.3%) | |
| Creatinine Increased Grade 1 & 2 | 1/12 (8.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough Grade 1 & 2 | 1/12 (8.3%) | |
| Pulmonary Edema Grade 1 & 2 | 1/12 (8.3%) | |
| Sinus Congestion Grade 1 & 2 | 1/12 (8.3%) | |
| Orthopnea Grade 3 & 4 | 1/12 (8.3%) | |
| Pulmonary Edema Grade 3 & 4 | 1/12 (8.3%) | |
| Pulmonary Emboli Grade 3 & 4 | 1/12 (8.3%) | |
| Shortness of Breath Grade 3 & 4 | 1/12 (8.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Rash Grade 1 & 2 | 1/12 (8.3%) | |
| Nail Changes Grade 1 & 2 | 1/12 (8.3%) | |
| Dry Skin Grade 1 & 2 | 1/12 (8.3%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sigrun Hallmeyer, MD Director of Research |
|---|---|
| Organization | Oncology Specialists SC |
| Phone | 847-268-8200 |
| shallmeyer@oncmed.net |
- 0606