A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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 phase II randomized protocol comparing EPOCH with sequential versus concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer cART is left to the discretion of the treating physician and the patient. While the AMC phase II study may establish an acceptable chemotherapy regimen suitable for further study in a phase III randomized trial, the results will not address adherence, pharmacokinetic interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to demonstrate the feasibility of co-administering cART with chemotherapy would justify the use of combined therapy in future AMC/International phase III protocols.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Hoffmann-La Roche
• Treatments: Prednisone; Vincristine

Criteria

Inclusion Criteria:

1. HIV seropositivity

2. 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

3. Age 18 years or older

Exclusion Criteria

1. Performance status ≥3 according to ECOG (Zubrod) scale (see Appendix I)

2. Known primary central nervous system lymphoma or parenchymal brain involvement with lymphoma

3. Non-measurable disease by physical examination or radiographic evaluation

4. Absolute CD4+ cell count <50 cells/mm3 within 3 months prior to trial initiation

5. 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.

6. Inadequate renal function (serum creatinine ≥125µmol/L) unless directly attributable to lymphoma

7. 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.

8. 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

9. Pregnant or lactating women who intend to breast-feed during the trial period

10. Men of reproductive potential and women of childbearing potential who are not using or not willing to use effective contraception

11. Known intolerance to the prescribed chemotherapy or antiretroviral drugs

12. Life-expectancy ≤ 3 months

13. Geographically inaccessible for follow-up