Lymphoma, Non-HodgkinPhase 2VRCDNCT00413959
VELCADE,Rituximab,Cyclophosphamide and Decadron
A Phase 2 study testing VELCADE®, Rituximab and Cyclophosphamide in people with Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, run by Oncology Specialists, S.C. at 2 sites in United States.
Trial summary
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
- What is being tested?
- VELCADE®, Rituximab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Known HIV positive status
- Known CNS involvement
- Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Onocology Specialists, S.C
Niles, Illinois, 60714
Oncology Specialists, S.C
Park Ridge, Illinois, 60068
About this study
Official title: Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
Read the 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.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
- Being tested
- VELCADE®, Rituximab, Cyclophosphamide, Decadron
- Keywords
- NHL
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADE®Drug
Also called Bortezomib
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
RituximabDrug
Also called Rituxan
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.
CyclophosphamideDrug
Also called Cytoxan
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
DecadronDrug
Also called dexamethasone
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
| Study group | Role | What they receive |
|---|---|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | Experimental | 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. Receives: Drug: VELCADE®; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Decadron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Overall Survival
The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Specialists, S.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
- Investigators
- Chadi Nabhan, MD, Principal investigator, Oncology Specialists, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413959
- Sponsor's protocol ID
- 0606
- Acronym
- VRCD
- Status last verified
- Aug 2018
- First submitted
- 19 Dec 2006
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00413959
- Acronym / sponsor ID
- VRCD / 0606
- Conditions
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
- Keywords
- NHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oncology Specialists, S.C.University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Aug 2006 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Dec 2006 (estimated)
- Results
- Posted 27 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Velcade, Rituximab,Cyclophosphamide & Decadron | Experimental | Drug: VELCADE®, Drug: Rituximab, Drug: Cyclophosphamide, Drug: DecadronVelcade 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Known HIV positive status
- Known CNS involvement
- Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VELCADE®Also: Bortezomib1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22. | Drug | Velcade, Rituximab,Cyclophosphamide & Decadron |
| RituximabAlso: Rituxan375 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. | Drug | Velcade, Rituximab,Cyclophosphamide & Decadron |
| CyclophosphamideAlso: Cytoxan400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle. | Drug | Velcade, Rituximab,Cyclophosphamide & Decadron |
| DecadronAlso: dexamethasone40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23 | Drug | Velcade, Rituximab,Cyclophosphamide & Decadron |
Primary outcome
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Time frame: 4 years
Percentage of complete responders plus percentage of partial responders equals overall response rate.
1 secondary outcome
Overall Survival
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chadi Nabhan, MD principal investigator
Oncology Specialists, SC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VELCADE®, Rituximab and Cyclophosphamide in people with Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, run by Oncology Specialists, S.C. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.