Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas

Launched by ONTARIO CLINICAL ONCOLOGY GROUP (OCOG) · Mar 28, 2007

Keywords

ClinConnect Summary

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, they have an overall poorer prognosis than B-cell lymphomas, achieving lower complete response rates, freedom from progression and overall survival with conventional anthracycline-based CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Fewer than 30% of patients are cured with therapy. New treatments that replicate the improved survivals with chemo-immunotherapy f...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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