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Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas: A Multi-centre Phase I and II Study

Phase 1/Phase 2
18 Years
Open (Enrolling)
Peripheral T-cell Lymphomas

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Trial Information

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.

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:


- Peripheral T-cell lymphoma not otherwise specified (PTL NOS)

- Angioimmunoblastic lymphadenopathy (AILD)

- ALK 1 negative anaplastic large cell NHL


- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

8 cycles of treatment

Safety Issue:


Principal Investigator

Rena Buckstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre, Odette Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

September 2006

Completion Date:

June 2016

Related Keywords:

  • Peripheral T-Cell Lymphomas
  • AILD
  • NHL
  • CHOP
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral