Non-Hodgkin's LymphomaPhase 2NCT00183976
Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas
A Phase 2 study testing Pegylated Liposomal Doxorubicin (Doxil) and Rituximab in people with Non-Hodgkin's Lymphoma and Burkitt Lymphoma, run by University of Southern California at 1 site in United States.
Trial summary
This study is for patients who have been treated before and either the treatment did not work or the lymphoma has come back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Burkitt Lymphoma, Primary Effusion Lymphomas
- What is being tested?
- Pegylated Liposomal Doxorubicin (Doxil) and Rituximab
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented B-cell non-Hodgkin's lymphoma [NHL] (diffuse mixed, diffuse or follicular large B-cell, immunoblastic), Burkitt or Burkitt-like lymphomas, and primary effusion lymphomas.
- Seropositive for HIV by any approved test (prior documentation of HIV seropositivity is acceptable).
- Failed or relapsed after at least 1 prior chemotherapy treatment (chemotx) regimen but could have had no more than 2 prior chemotx regimens with only one of them being an anthracycline-containing regimen. Prior treatment (tx) with rituximab allowed.
- All stages of disease
- Measurable or evaluable tumor
- Greater than or equal to 18 years of age
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- Karnofsky performance status greater than 50%
- Absolute granulocyte count (AGC) greater than 1.0; platelets greater than 75,000; hemoglobin (Hgb) greater than 8.0 (unless these parameters are abnormal secondary to lymphomatous involvement of marrow, or due to HIV-related thrombocytopenia).
- Bilirubin less than 2.0 (unless elevated secondary to lymphomatous involvement of liver or biliary system or due to other HIV-related medications such as Crixivan).
- Creatinine less than 2.5 or creatinine clearance greater than 60 ml/min
- Multigated acquisition (MUGA) scan or 2D echocardiogram indicating left ventricular ejection fraction (LVEF) greater than or equal to 50% within 42 days prior to first dose of study drug.
- Patients with central nervous system (CNS) involvement are eligible provided that systemic lymphomatous disease is also present.
- Concurrent therapy for HIV with any licensed agent or an agent available on an expanded access program will be required.
- Signed informed consent including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
Who cannot join
- Acute intercurrent infection that may interfere with planned protocol. Patients with mycobacterium avium are not excluded. Chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met.
- Second active tumor. Patients with non-melanomatous skin cancer, in-situ cervical cancer, or Kaposi's sarcoma, not requiring systemic chemotherapy may be entered on study.
- Primary CNS lymphoma.
- Documented history of congestive heart failure (CHF), hemodynamically unstable arrhythmia, myocardial infarction (MI) in the preceding 6 months, or evidence on electrocardiogram (EKG) of untreated cardiac ischemia.
- Prior exposure to a liposomal anthracycline (liposomal doxorubicin or daunorubicin) for the treatment of lymphoma. Prior exposure to conventional doxorubicin allowed.
- Prior radiation therapy within 4 weeks, unless for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)
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- Prior systemic chemotherapy or biologic therapy within 3 weeks
- History of hypersensitivity reaction to anthracyclines or granulocyte colony-stimulating factor (G-CSF)
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride (HCl)
- Investigational agent(s) within 4 weeks of start of study therapy.
- History of cardiac disease with New York Heart Association (NYHA) greater than or equal to Class II, or clinical evidence of CHF
- Pregnant or nursing mothers.
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 Pilot Phase II Study of Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas
This study is for patients who have been treated before and either the treatment did not work or the lymphoma has come back.
- Being tested
- Pegylated Liposomal Doxorubicin (Doxil) and Rituximab
- Keywords
- Diffuse mixed NHL, Diffuse or follicular large B-cell NHL, Immunoblastic NHL, Burkitt or Burkitt-like lymphomas
- Medical subject headings
- Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Lymphoma, Primary Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Liposomal Doxorubicin (Doxil) and RituximabDrug
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 startApr 2005
- Primary completionSep 2005
- Study completionJan 2006
Why it stopped: Insufficient 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil Tulpule, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183976
- Sponsor's protocol ID
- 17NHL-03-2
- Status last verified
- May 2006
- First submitted
- 12 Sep 2005
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study of Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT00183976
- Acronym / sponsor ID
- 17NHL-03-2
- Keywords
- Diffuse mixed NHL, Diffuse or follicular large B-cell NHL, Immunoblastic NHL, Burkitt or Burkitt-like lymphomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 15 participants
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Sep 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.
This study is for patients who have been treated before and either the treatment did not work or the lymphoma has come back.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (14 listed)
- Histologically or cytologically documented B-cell non-Hodgkin's lymphoma [NHL] (diffuse mixed, diffuse or follicular large B-cell, immunoblastic), Burkitt or Burkitt-like lymphomas, and primary effusion lymphomas.
- Seropositive for HIV by any approved test (prior documentation of HIV seropositivity is acceptable).
- Failed or relapsed after at least 1 prior chemotherapy treatment (chemotx) regimen but could have had no more than 2 prior chemotx regimens with only one of them being an anthracycline-containing regimen. Prior treatment (tx) with rituximab allowed.
- All stages of disease
- Measurable or evaluable tumor
Key exclusion criteria (12 listed)
- Acute intercurrent infection that may interfere with planned protocol. Patients with mycobacterium avium are not excluded. Chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met.
- Second active tumor. Patients with non-melanomatous skin cancer, in-situ cervical cancer, or Kaposi's sarcoma, not requiring systemic chemotherapy may be entered on study.
- Primary CNS lymphoma.
- Documented history of congestive heart failure (CHF), hemodynamically unstable arrhythmia, myocardial infarction (MI) in the preceding 6 months, or evidence on electrocardiogram (EKG) of untreated cardiac ischemia.
- Prior exposure to a liposomal anthracycline (liposomal doxorubicin or daunorubicin) for the treatment of lymphoma. Prior exposure to conventional doxorubicin allowed.
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 |
|---|---|---|
| Pegylated Liposomal Doxorubicin (Doxil) and Rituximab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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 Pegylated Liposomal Doxorubicin (Doxil) and Rituximab in people with Non-Hodgkin's Lymphoma and Burkitt 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 14 inclusion and 12 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 22 May 2014. 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?
The study was stopped early (reason given: Insufficient 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.
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 22 May 2014.