Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma

August 23, 2013 updated by: Cancer Research UK

CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds General Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-113-392-3766
      • London, England, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden - London
        • Contact:
          • Contact Person
          • Phone Number: 44-20-7352-8171
      • London, England, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-20-3299-9000
      • Manchester, England, United Kingdom, M20 4BX
        • Recruiting
        • Christie Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-161-446-8565
      • Torbay Devon, England, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-180-365-5260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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)

PRIOR CONCURRENT THERAPY:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immediate toxicity (incidence of infusion-related reactions)
Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research UK

Investigators

  • Study Chair: Roderick Johnson, MD, Leeds General Infirmary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000576439
  • UCL-BRD/05/170
  • EU-20785
  • EUDRACT-2006-000365-11
  • CTA 21786/0201/001-0001
  • CRUK-UCL-BRD/05/170-CHOP-CAMPA
  • UCL-CHOP-CAMPATH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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