Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas: A Multi-centre Phase I and II Study
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 for B-cell
lymphomas are needed. Alemtuzumab is a humanized murine antibody that binds to a ubiquitous
lymphoid marker CD52 and is efficacious (as monotherapy) in related lymphoproliferative
diseases. Combining alemtuzumab with CHOP chemotherapy may improve the response rates and
outcomes of patients with this sub-type of NHL. The combination must be first tested in a
dose escalation fashion to establish the dosage of the doublet because of the potential for
overlapping or exaggerated toxicities.
This prospective, multi-center, open label Phase I-II study will enroll 22-84 patients with
newly diagnosed previously untreated aggressive histology peripheral T-cell lymphomas. In
the Phase I component, patients will be sequentially enrolled in cohorts of three patients
and treated with increasing doses of alemtuzumab administered in combination with standard
CHOP chemotherapy. When the maximal tolerated dose is determined, this dose and schedule
will then be tested in up to 46 patients using a Simon two stage Phase II design.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
toxicity
8 cycles of treatment
Yes
Rena Buckstein, MD
Principal Investigator
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Canada: Health Canada
CTA-Control-103662
NCT00453427
September 2006
June 2016
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