Non-Hodgkin's LymphomaPhase 2NCT00184002
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
A Phase 2 study testing Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone in people with Non-Hodgkin's Lymphoma, run by University of Southern California at 1 site in United States.
Trial summary
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2003to 7 May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like lymphoma
- All stages of disease
- Measurable or evaluable tumor parameter(s)
- Age greater than 17 years old
- Karnofsky performance status greater or equal to 50%
- AGC greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma)
Show all 12Show fewer
- Bilirubin less or equal to 2.0; SGOT less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma)
- Creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma)
- LVEF greater or equal to 45%
- Concurrent RT with or without steroids for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)are permitted
- Men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy
- Signed informed consent
Who cannot join
- Prior systemic cytotoxic therapy or RT for lymphoma
- Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
- HIV seropositive
- Primary CNS lymphoma
- Pregnant or nursing women
- Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033
About this study
Official title: A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
- 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.
Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and PrednisoneDrug
Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.
Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.
Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).
Prednisone 100 mg po days 1-5.
Cycle 2 until study completion
Doxil 40 mg/m2 iv day 1
Rituxan 375 mg/m2 iv day 1
Cyclophosphamide 750 mg/m2 iv day 1
Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum)
Prednisone 100 mg po days 1-5
- 1 cycle = 21 days.
- Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| DR-COP | Experimental | On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.
On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5
* 1 cycle = 21 days.
* Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. Receives: Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Complete Response to the Combination Chemotherapy
Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.
Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23).
Measured: At completion of cycle 4, 6, and 8
Secondary outcomes (1)
Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.
Measured: At end of every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start10 Jan 2003
- Primary completion19 Dec 2012
- Study completion7 May 2013
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 Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Anil Tulpule, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184002
- Sponsor's protocol ID
- 13NHL-02-3
- Status last verified
- Jul 2017
- First submitted
- 12 Sep 2005
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00184002
- Acronym / sponsor ID
- 13NHL-02-3
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Ortho Biotech, Inc.
- Study start
- 10 Jan 2003 (actual)
- Primary completion
- 19 Dec 2012 (actual)
- Study completion
- 7 May 2013 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DR-COP | Experimental | Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and PrednisoneOn cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like lymphoma
- All stages of disease
- Measurable or evaluable tumor parameter(s)
- Age greater than 17 years old
- Karnofsky performance status greater or equal to 50%
Key exclusion criteria (6 listed)
- Prior systemic cytotoxic therapy or RT for lymphoma
- Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
- HIV seropositive
- Primary CNS lymphoma
- Pregnant or nursing women
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 |
|---|---|---|
| Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and PrednisoneCycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) Prednisone 100 mg po days 1-5 * 1 cycle = 21 days. * Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles. | Drug | DR-COP |
Primary outcome
Percentage of Patients With Complete Response to the Combination Chemotherapy
Time frame: At completion of cycle 4, 6, and 8
Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23).
1 secondary outcome
Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
Time frame: At end of every cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- 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.
Anil Tulpule, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone in people with Non-Hodgkin's Lymphoma, run by University of Southern California at 1 site 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 12 inclusion and 6 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: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 10 Aug 2017). 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?
Percentage of Patients With Complete Response to the Combination Chemotherapy (time frame: At completion of cycle 4, 6, and 8). 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 10 Aug 2017.