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:
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
  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:
  • Rituxan
  • Vepesid
  • Adriamycin
  • Vincristine
  • Cytoxan
  • Prednisone
  • Truvada
  • Sustiva

  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 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
  Contacts and Locations
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

No publications provided

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

ClinicalTrials.gov processed this record on April 20, 2014