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

Phase 1
18 Years
Open (Enrolling)
Lymphoma, Small Intestine Cancer

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Trial Information

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



- 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


- 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

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.

Inclusion Criteria


- 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:


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immediate toxicity (incidence of infusion-related reactions)

Safety Issue:


Principal Investigator

Roderick Johnson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Leeds General Infirmary



Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms