A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL (CATCH)
This study has been completed.
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00799136
First received: November 26, 2008
Last updated: September 11, 2013
Last verified: September 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, AIDS Related HIV Infections |
Drug: R-EPOCH and cART |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Feasibility Study of CO-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of Acquired Immunodeficiency Syndrome (AIDS)-Related Lymphoma |
Resource links provided by NLM:
Further study details as provided by Ontario Clinical Oncology Group (OCOG):
Primary Outcome Measures:
- The primary outcome for this feasibility study will be medication adherence. Acceptable adherence, defined as compliance to ≥90% of all prescribed doses of cART during the course of chemotherapy, will be measured by pill counting and patient self-report [ Time Frame: 4 -6 weeks after 6 cycles of R-EPOCH ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity Lymphoma response Rate Progression -free Survival and Overall Survival Pharmacokinetics [ Time Frame: 2 years post completion ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | February 2008 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
One
Rituxan with EPOCH and Antiretrovirals
|
Drug: R-EPOCH and cART
This is a prospective, single-arm, multi-centre, phase II trial of immuno-chemotherapy (rituximab and EPOCH) with mandatory combination antiretroviral therapy for initial treatment of AIDS-related lymphoma.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00799136
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799136
Locations
| Canada, Ontario | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Hoffmann-La Roche
Investigators
| Principal Investigator: | Matthew Cheung, Dr. . | Odette Cancer Centre |
More Information
| Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
| ClinicalTrials.gov Identifier: | NCT00799136 History of Changes |
| Other Study ID Numbers: | OCOG-2007-CATCH CIHR FRN 79390 |
| Study First Received: | November 26, 2008 |
| Last Updated: | September 11, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
Lymphoma Large B Cell Diffuse Acquired Immunodeficiency |
Additional relevant MeSH terms:
|
Lymphoma HIV Infections Acquired Immunodeficiency Syndrome Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Slow Virus Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on September 29, 2016