Status:
COMPLETED
Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Genzyme, a Sanofi Company
Conditions:
Peripheral T-cell Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objectives of this study are to: 1. establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell l...
Detailed Description
Aggressive peripheral T-cell lymphomas account for 10 - 15% of all Non-Hodgkin's Lymphoma (NHL) and present with more adverse prognostic features than aggressive histology B-cell NHL . Correspondingly...
Eligibility Criteria
Inclusion
- Patients aged 18 years of age or older at time of enrollment,
- Histologically proven and centrally reviewed CD52+ T-cell NHL Stages 2-4 including the following nodal and extranodal subtypes:
- Nodal:
- Peripheral T-cell lymphoma not otherwise specified (PTL NOS)
- Angioimmunoblastic lymphadenopathy (AILD)
- ALK 1 negative anaplastic large cell NHL
- Extranodal:
- Hepatosplenic
- Enteropathy-associated
- Panniculitic
Exclusion
- Previous treatment with chemotherapy or radiation with the exception of up to 1 cycle of CHOP chemotherapy.
- Expected survival \< 4 months.
- ECOG performance status \> 3.
- Inadequate haematologic function (Hb \< 85g/L, ANC \< 1000/mm3, or platelet count \< 75,000/mm3) unless directly attributable to the NHL.
- Inadequate hepatic function (total bilirubin \> 35μmol/L, alkaline phosphatase \> 2x UL normal, AST/ALT \> 2x UL normal)
- Inadequate renal function (serum creatinine \> 130μmol/L), unless directly attributable to the NHL.
- Non-measurable or non-evaluable disease, according to criteria of Cheson et al49.
- Geographically inaccessible for follow-up
- Known hypersensitivity to study drugs
- Serious illnesses that may interfere with subject compliance, determination of causality of adverse events or would compromise other protocol objectives.
- Known HIV positivity or other pre-existing immunodeficiency (e.g., post-organ transplant).
- Known CNS involvement with lymphoma (tests to investigate CNS involvement are required only if clinically indicated).
- Pregnant or lactating women.
- Women who are of childbearing potential but are not using effective contraception. Men with reproductive potential who are not using effective contraception.
- Previous malignancy within the last 5 years with the exception of cervical carcinoma in situ or non melanoma skin cancer.
- Nasal natural killer (NK) T-cell NHL
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00453427
Start Date
September 1 2006
End Date
May 1 2015
Last Update
June 3 2015
Active Locations (5)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
3
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
4
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5