Non-Hodgkin's LymphomaPhase 2NCT00120198
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
A Phase 2 study testing CDOP plus rituximab in people with Non-Hodgkin's Lymphoma, run by Geriatric Oncology Consortium at 5 sites in United States.
Trial summary
Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- CDOP plus rituximab
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2005to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years and older;
- Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered;
- Previously untreated;
- ECOG 0-2
- Adequate renal and hepatic functions;
- Cardiac ejection fraction at least 50% by MUGA. No significant cardiac abnormalities by EKG;
- Signed informed consent
Who cannot join
- CNS involvement by lymphoma;
- Hypersensitivity to study drugs;
- Active infection;
- Prior treatment with monoclonal antibodies for cancer;
- History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Belleville, New Jersey, 07109
Study site
Inverness, Florida, 34452
Study site
Lecanto, Florida, 34461
Study site
Oxnard, California, 93030
Study site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Pilot Study of Cyclophosphamide/Pegylated Liposomal Doxorubicin/Vincristine/Prednisone (CDOP) Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkin's Lymphoma
Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.
Read the detailed description
Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) less well when compared to the younger population. Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin. Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted. Both safety and efficacy will be evaluated.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- CDOP plus rituximab
- Keywords
- NHL, elderly
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDOP plus rituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Secondary outcomes (4)
Tumor response
duration of response
median time to disease progression
overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startMar 2005
- Study completionSep 2006
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geriatric Oncology Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Tibotec Pharmaceutical Limited
- Investigators
- Lodovico Balducci, MD, Study chair, Geriatric Oncology Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120198
- Sponsor's protocol ID
- GOC-LY-010
- Status last verified
- Nov 2007
- First submitted
- 8 Jul 2005
- Last updated
- 16 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cyclophosphamide/Pegylated Liposomal Doxorubicin/Vincristine/Prednisone (CDOP) Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00120198
- Acronym / sponsor ID
- GOC-LY-010
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- NHL, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Geriatric Oncology ConsortiumUniversity, hospital or other
- Collaborators
- Tibotec Pharmaceutical Limited
- Study start
- Mar 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.
Detailed description
Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) less well when compared to the younger population. Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin. Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted. Both safety and efficacy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 years and older;
- Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered;
- Previously untreated;
- ECOG 0-2
- Adequate renal and hepatic functions;
Key exclusion criteria (5 listed)
- CNS involvement by lymphoma;
- Hypersensitivity to study drugs;
- Active infection;
- Prior treatment with monoclonal antibodies for cancer;
- History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
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 |
|---|---|---|
| CDOP plus rituximab | Drug | – |
Primary outcome
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
4 secondary outcomes
Tumor response
duration of response
median time to disease progression
overall survival
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2007.
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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.
Lodovico Balducci, MD study chair
Geriatric Oncology Consortium
5 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 CDOP plus rituximab in people with Non-Hodgkin's Lymphoma, run by Geriatric Oncology Consortium at 5 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 7 inclusion and 5 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 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
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?
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.. 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 16 Nov 2007.