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A Feasibility Study of Co-Administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL (CATCH)
This study is currently recruiting participants.
Verified by Ontario Clinical Oncology Group (OCOG), November 2008
First Received: November 26, 2008   Last Updated: December 17, 2008   History of Changes
Sponsors and Collaborators: Ontario Clinical Oncology Group (OCOG)
Hoffmann-La Roche
Information provided by: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00799136
  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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment: 18
Study Start Date: October 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2009 (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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV seropositivity
  2. Biopsy diagnosis of a CD20+ diffuse large B-cell lymphoma diagnosed according to the World Health Organization (WHO) classification
  3. Advanced disease (stage III or IV according to Ann Arbor staging system)
  4. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799136

Contacts
Contact: Betsy A MacKinnon, HBA MSc 905 527 2299 ext 42606 mackinn@mcmaster.ca
Contact: Donna McCarty 905 527 2299 ext 42605 mccartyd@mcmaster.ca

Locations
Canada, Ontario
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Matthew Cheung, Dr.     416 480 5847     matthew.cheung@sunnybrook.ca    
Principal Investigator: Matthew Cheung, Dr.            
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Hoffmann-La Roche
Investigators
Principal Investigator: Matthew Cheung, Dr. . Odette Cancer Centre
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group ( Dr. Mark Levine Director OCOG )
Study ID Numbers: OCOG-2007-CATCH, CIHR FRN 79390
Study First Received: November 26, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00799136     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Lymphoma Large B Cell Diffuse
Acquired Immunodeficiency

Study placed in the following topic categories:
Lymphoma, AIDS-related
Prednisone
Efavirenz
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Rituximab
Acquired Immunodeficiency Syndrome
Vincristine
Cyclophosphamide
Etoposide phosphate
Doxorubicin
Immunologic Deficiency Syndromes
Virus Diseases
Lymphoma, B-Cell
Lymphatic Diseases
B-cell Lymphomas
Lymphoma, AIDS-Related
HIV Infections
Sexually Transmitted Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Etoposide
Lymphoma
Retroviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Lymphoma, B-Cell
Virus Diseases
Lymphatic Diseases
Neoplasms
Lymphoma, AIDS-Related
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Retroviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009