A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL (CATCH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00799136 |
Recruitment Status
:
Completed
First Posted
: November 27, 2008
Last Update Posted
: September 12, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma, AIDS Related HIV Infections | Drug: R-EPOCH and cART | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | September 2013 |
Arm | Intervention/treatment |
---|---|
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:
|
- 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 ]
- Toxicity Lymphoma response Rate Progression -free Survival and Overall Survival Pharmacokinetics [ Time Frame: 2 years post completion ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799136
Canada, Ontario | |
Odette Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 |
Principal Investigator: | Matthew Cheung, Dr. . | Odette Cancer Centre |
Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00799136 History of Changes |
Other Study ID Numbers: |
OCOG-2007-CATCH CIHR FRN 79390 |
First Posted: | November 27, 2008 Key Record Dates |
Last Update Posted: | September 12, 2013 |
Last Verified: | September 2013 |
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 |