Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lym… (NCT00183976) | Clinical Trial Compass
TerminatedPhase 2
Pegylated Liposomal Doxorubicin (Doxil) With Rituximab in Relapsed AIDS-Related Non-Hodgkin's Lymphomas
Stopped: Insufficient Accrual
United States15 participantsStarted 2005-04
Plain-language summary
This study is for patients who have been treated before and either the treatment did not work or the lymphoma has come back.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
* 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 tha…