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

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

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



- Establish the safety and dose-limiting toxicities of alemtuzumab in combination with
cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP)
chemotherapy in patients with newly diagnosed, stage II-IV aggressive peripheral T-cell
non-Hodgkin's lymphoma.

- Measure the pharmacokinetics of alemtuzumab using different subcutaneous doses and
schedules to determine the dose with the highest achievable drug levels with acceptable
toxicities worthy of further investigation.


- Determine the efficacy of alemtuzumab in combination with CHOP chemotherapy using
escalating doses and 2 different drug schedules, as defined by overall response rate,
progression-free survival, and overall survival.

- Measure the effects of this regimen on T-cell reconstitution and cytomegalovirus

OUTLINE: This is a multicenter, phase I, dose-escalation study of alemtuzumab followed by an
open-label, phase II study.

- Phase I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin
hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients
also receive alemtuzumab subcutaneously (SC) on day 1 OR on days 1, 8, and 15.
Treatment repeats every 3 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of alemtuzumab until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive CHOP chemotherapy and alemtuzumab (at the MTD determined in
phase I) as in phase I (on the most effective regimen).

Patients undergo blood collection at baseline, periodically during study treatment, and
after completion of study treatment for pharmacokinetics and other correlative studies.
Samples are examined for presence of cytomegalovirus antigen and by flow cytometry for B-
and T-cell quantification.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed aggressive peripheral T-cell non-Hodgkin's lymphoma (NHL),
including the following nodal or extranodal subtypes:

- Nodal:

- Angioimmunoblastic lymphadenopathy

- ALK 1-negative anaplastic large cell NHL

- Peripheral T-cell lymphoma not otherwise specified

- Extranodal:

- Hepatosplenic NHL

- Enteropathy-associated NHL

- Panniculitic NHL

- Stage II-IV disease

- Newly diagnosed, CD52+ disease

- Measurable or evaluable disease

- No known CNS involvement with lymphoma

- No nasal natural killer T-cell NHL


- ECOG performance status 0-2

- Life expectancy > 4 months

- Absolute neutrophil count ≥ 1,000/mm³*

- Platelet count ≥ 75,000/mm³*

- Hemoglobin ≥ 8.5 g/dL*

- Bilirubin < 2.0 mg/dL

- Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)

- AST or ALT < 2 times ULN

- Creatinine < 1.5 mg/dL*

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known hypersensitivity to any of the study drugs

- No serious illnesses that would preclude compliance with study requirements

- No known HIV positivity

- No other preexisting immunodeficiency (e.g., post-organ transplant)

- No other malignancy within the past 5 years except cervical carcinoma in situ or
nonmelanoma skin cancer NOTE: *Unless directly attributable to NHL


- No prior chemotherapy or radiotherapy

- Up to 7 days of prednisone preceding initiation of chemotherapy allowed

- No other concurrent chemotherapy, radiotherapy, or immunotherapy

- No other concurrent corticosteroids except dexamethasone used as an antiemetic for a
brief period

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0

Safety Issue:


Principal Investigator

Rena Buckstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook



Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral