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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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

November 20, 2007
November 21, 2007
August 26, 2013
May 2007
May 2009   (Final data collection date for primary 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)
Same as current
Complete list of historical versions of study NCT00562068 on ClinicalTrials.gov Archive Site
  • 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)
  • Relative dose intensity
  • Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
  • Epstein-Barr virus copy number (measured retrospectively)
Same as current
Not Provided
Not Provided
 
Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma
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.

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.

Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Not Provided
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00562068
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
Not Provided
Not Provided
Not Provided
Not Provided
Cancer Research UK
Not Provided
Study Chair: Roderick Johnson, MD Leeds General Infirmary
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP