Diffuse Large B Cell LymphomaPhase 2NCT00333008
A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
A Phase 2 study testing Doxil, Cyclophosphamide and Vincristine in people with Diffuse Large B Cell Lymphoma and Lymphoma, Non-Hodgkin, run by The Alvin and Lois Lapidus Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Lymphoma, Non-Hodgkin
- What is being tested?
- Doxil, Cyclophosphamide and Vincristine
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
- Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
- Previously untreated
- New York Heart Association (NYHA) classification of Class III or better
- Baseline ejection fraction (EF) > 25%
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
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- Unless attributable to NHL: absolute neutrophil count (ANC) > 1500/uL, platelets > 100,000/uL; hemoglobin > 9.0 g/dl
- Bilirubin < 1.5 mg/dL (unless related to lymphoma)
- Hepatic: transaminases < 2.5 x upper limit of normal (ULN) (unless related to lymphoma)
- Creatinine < 2.5 mg/dl (unless related to lymphoma)
Who cannot join
- No HIV+ individuals
- No primary central nervous system (CNS) lymphoma
- No pregnant or lactating women
- No serious active infection
- History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Pam Nickoles, RN, BSN, 410-601-0729, pnickole@lifebridgehealth.org
Judy Bosley, RN, BSN, 410-601-4392, jbosley@lifebridgehealth.org
- Recruiting
Northwest Hospital Center
Randallstown, Maryland, 21133
Pam Nickoles, RN, BSN, 410-601-0729, pnickole@lifebridgehealth.org
Judy Bosley, RN, BSN, 410-601-4392, jbosley@lifebridgehealth.org
About this study
Official title: Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status
The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality. The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients. Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population. For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome. In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments. This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin. Growth factor will be used for support of acceptable blood counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.
- Being tested
- Doxil, Cyclophosphamide, Vincristine, Prednisone, Rituximab
- Keywords
- Diffuse Large B Cell Lymphoma, CDOP, Dose Dense, Anne Arbor Stage I-IV, Any IPI score
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxilDrug
CyclophosphamideDrug
VincristineDrug
PrednisoneDrug
RituximabDrug
PegfilgrastimDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
Efficacy: tumor evaluations every three (q 3) cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants
Sponsor and investigators
- Lead sponsor
- The Alvin and Lois Lapidus Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech Products, L.P.
- Investigators
- Stephen Noga, MD, PhD, Principal investigator, Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333008
- Sponsor's protocol ID
- LY-012006
- Status last verified
- Sep 2006
- First submitted
- 31 May 2006
- Last updated
- 26 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status
- ClinicalTrials.gov ID
- NCT00333008
- Acronym / sponsor ID
- LY-012006
- Keywords
- Diffuse Large B Cell Lymphoma, CDOP, Dose Dense, Anne Arbor Stage I-IV, Any IPI score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants
- Lead sponsor
- The Alvin and Lois Lapidus Cancer InstituteUniversity, hospital or other
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- May 2006
- First posted
- 2 Jun 2006 (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.
The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.
Detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality. The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients. Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population. For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome. In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments. This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin. Growth factor will be used for support of acceptable blood counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
- Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
- Previously untreated
- New York Heart Association (NYHA) classification of Class III or better
- Baseline ejection fraction (EF) > 25%
Key exclusion criteria (5 listed)
- No HIV+ individuals
- No primary central nervous system (CNS) lymphoma
- No pregnant or lactating women
- No serious active infection
- History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.
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 |
|---|---|---|
| Doxil | Drug | – |
| Cyclophosphamide | Drug | – |
| Vincristine | Drug | – |
| Prednisone | Drug | – |
| Rituximab | Drug | – |
| Pegfilgrastim | Drug | – |
Primary outcome
Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
Efficacy: tumor evaluations every three (q 3) cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2006.
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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.
Stephen Noga, MD, PhD principal investigator
Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute
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 Doxil, Cyclophosphamide and Vincristine in people with Diffuse Large B Cell Lymphoma and Lymphoma, Non-Hodgkin, run by The Alvin and Lois Lapidus Cancer Institute 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 10 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: status not confirmed, as of the sponsor's last update on 26 Sep 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pam Nickoles, RN, BSN (410-601-0729, pnickole@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0. The study lists 2 primary outcomes in all. 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 26 Sep 2006.