Status:
COMPLETED
A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Lymphoma, AIDS Related
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently administering a phas...
Detailed Description
Study Design \& Duration This is a prospective, single-arm, multi-centre, phase II trial of immuno-chemotherapy (rituximab and EPOCH) with mandatory combination antiretroviral therapy for initial trea...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- HIV seropositivity
- Biopsy diagnosis of a CD20+ diffuse large B-cell lymphoma or variants (including mediastinal (thymic) large B-cell lymphoma and plasmablastic lymphoma), atypical Burkit/Burkitt-like lymphoma, or Burkitt lymphoma diagnosed according to the World Health Organization (WHO) classification
- Age 18 years or older
- Exclusion Criteria
- Performance status ≥3 according to ECOG (Zubrod) scale (see Appendix I)
- Known primary central nervous system lymphoma or parenchymal brain involvement with lymphoma
- Non-measurable disease by physical examination or radiographic evaluation
- Absolute CD4+ cell count \<50 cells/mm3 within 3 months prior to trial initiation
- Inadequate hepatic function (total bilirubin ≥35 µmol/L, alkaline phosphatase ≥2 xUL normal, AST/ALT ≥2 xUL normal) unless directly attributable to lymphoma or known Hepatitis B or C co-infection.
- Inadequate renal function (serum creatinine ≥125µmol/L) unless directly attributable to lymphoma
- Inadequate haematological function (haemoglobin ≤85 g/L, absolute neutrophil count ≤1000 cells/mm3, platelet count ≤75,000 cells/mm3) unless directly attributable to lymphoma or autoimmune thrombocytopenia.
- Evidence of left ventricular (LV) dysfunction (ejection fraction ≤ 50%) in patients over the age of 60 or in patients with a prior history of hypertension, congestive heart failure, peripheral vascular disease, cerebrovascular disease, coronary artery disease, or cardiac arrhythmia
- Pregnant or lactating women who intend to breast-feed during the trial period
- Men of reproductive potential and women of childbearing potential who are not using or not willing to use effective contraception
- Known intolerance to the prescribed chemotherapy or antiretroviral drugs
- Life-expectancy ≤ 3 months
- Geographically inaccessible for follow-up
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00799136
Start Date
February 1 2008
End Date
September 1 2013
Last Update
September 12 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8