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Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363090
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 15, 2006
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: alemtuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Other: flow cytometry Other: pharmacological study Phase 1 Phase 2

Detailed Description:



  • 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 reactivation.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study
Study Start Date : September 2006
Estimated Primary Completion Date : December 2010

Primary Outcome Measures :
  1. Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0
  2. Safety
  3. Dose-limiting toxicities
  4. Pharmacokinetics of alemtuzumab

Secondary Outcome Measures :
  1. Efficacy as assessed by clinical, radiologic, pathologic, and laboratory measurements
  2. Overall response rate
  3. Progression-free survival
  4. Overall survival
  5. Effects of treatment on T- and B-cell reconstitution by flow cytometry at baseline and at 3, 6, and 12 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363090

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Canada, British Columbia
St. Paul's Hospital at Providence Health Care - Vancouver Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Contact Person    604-806-9656      
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, N6A 4L6
Contact: Graeme Fraser, MD, FRCPC    905-575-7820      
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Joy Mangel, MD    519-685-8615   
Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Rena Buckstein, MD    416-480-5847   
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael R. Crump, MD, FRCPC    416-946-4567   
Sponsors and Collaborators
Toronto Sunnybrook Regional Cancer Centre
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Study Chair: Rena Buckstein, MD Toronto Sunnybrook Regional Cancer Centre
Layout table for additonal information Identifier: NCT00363090    
Other Study ID Numbers: CDR0000491451
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists