CATCH
Feasibility Study of CO-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of Acquired Immunodeficiency Syndrome (AIDS)-Related Lymphoma
Sponsor study identifier
Secondary identifiers
interventional
6
1 country
2
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 26, 2008
Actual (reported)November 27, 2008
Actual (reported)December 2012
Actual (reported)September 2013
Actual (reported)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
4 -6 weeks after 6 cycles of R-EPOCH
Toxicity Lymphoma response Rate Progression -free Survival and Overall Survival Pharmacokinetics
2 years post completion
Rituxan with EPOCH and Antiretrovirals
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Matthew Cheung, Dr. .
Odette Cancer Centre
6 participants (actual enrollment reported by the registry).
First Submitted
November 26, 2008
First Posted
November 27, 2008
Study Start
February 2008
Date type not reportedThis date has not been verified as actual or estimated.
A Pilot Study of LTB4 in HIV-1 Infected Adults
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
September 12, 2013
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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