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A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL (CATCH)

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ClinicalTrials.gov Identifier: NCT00799136
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : September 12, 2013
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, AIDS Related HIV Infections Drug: R-EPOCH and cART Phase 2

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Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Lymphoma

Arms and Interventions
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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:
  • Rituxan
  • Vepesid
  • Adriamycin
  • Vincristine
  • Cytoxan
  • Prednisone
  • Truvada
  • Sustiva


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Toxicity Lymphoma response Rate Progression -free Survival and Overall Survival Pharmacokinetics [ Time Frame: 2 years post completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


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
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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