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Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell 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: NCT00562068
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 21, 2007
Last Update Posted : August 26, 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 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 trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Small Intestine Cancer Biological: alemtuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisolone Drug: vincristine sulfate Genetic: polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis Other: pharmacological study Phase 1

Detailed Description:



  • To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
  • To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.


  • To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
  • To monitor immune reconstitution after therapy.
  • To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
  • To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
  • To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.

OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.

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) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.

After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]
Study Start Date : May 2007
Estimated Primary Completion Date : May 2009

Primary Outcome Measures :
  1. Immediate toxicity (incidence of infusion-related reactions)
  2. Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
  3. Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)

Secondary Outcome Measures :
  1. Disease response (remission rate [complete response and partial response])
  2. Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
  3. Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
  4. Relative dose intensity
  5. Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
  6. Epstein-Barr virus copy number (measured retrospectively)

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


  • Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes:

    • PTCL not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma
    • Intestinal T-cell lymphoma
  • Bulky stage IA and stages IB-IV disease (Ann Arbor staging system)
  • Expression of CD52 by the tumor
  • Measurable or evaluable disease
  • No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma
  • No CNS involvement with non-Hodgkin lymphoma


  • WHO performance status 0-2
  • No presence of other serious, uncontrolled medical conditions
  • No significant anthracycline-related cardiac impairment
  • LVEF ≥ 50%
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2 times normal value unless due to disease
  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment
  • No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
  • No positive serology or non-consenting to test for any of the following:

    • HIV
    • Hepatitis B or C
    • Human T-lymphotropic virus type 1 (HTLV-1)


  • No prior cytotoxic chemotherapy
  • Prior radiotherapy may be allowed at the trial coordinator's discretion
  • Concurrent consolidation radiotherapy may be given at the clinician's discretion

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): NCT00562068

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United Kingdom
Leeds General Infirmary Recruiting
Leeds, England, United Kingdom, LS1 3EX
Contact: Contact Person    44-113-392-3766      
King's College Hospital Recruiting
London, England, United Kingdom, SE5 9RS
Contact: Contact Person    44-20-3299-9000      
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person    44-20-7352-8171      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-161-446-8565      
Torbay Hospital Recruiting
Torbay Devon, England, United Kingdom, TQ2 7AA
Contact: Contact Person    44-180-365-5260      
Sponsors and Collaborators
Cancer Research UK
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Study Chair: Roderick Johnson, MD Leeds General Infirmary
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00562068    
Other Study ID Numbers: CDR0000576439
CTA 21786/0201/001-0001
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: November 2008
Keywords provided by National Cancer Institute (NCI):
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
small intestine lymphoma
peripheral T-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action