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A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

Phase 1
18 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas

Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin
(Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against
different types of lymphoma for many years. Researchers are investigating what other
therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma.
The current study combines CHOP with alemtuzumab, a monoclonal antibody used against
leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of
cancer. They are produced in a laboratory and designed to target as well as bind with cells
that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express
a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This
antigen, or substance that causes the immune system to create a specific response, is
expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain
cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study
will also assess the theory that alemtuzumab may increase the effectiveness of the
chemotherapy agents included in the CHOP regimen.

Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be
given through injections into the skin and CHOP will be administered through intravenous
infusions. Patients will receive alemtuzumab alone during the first week of the study. An
increasing amount of alemtuzumab will be given during the first week. If patients cannot
tolerate the highest amount of alemtuzumab determined as appropriate within one week, they
will be removed from the study. Once the highest dose of alemtuzumab has been achieved,
patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will
be repeated up to eight times. Several tests and exams will be given throughout the study to
closely monitor patients. Treatments will be discontinued due to disease growth or
unacceptable side effects.

Inclusion Criteria:

- CD-20 Negative

- Previous treatment permitted: radiation, electron beam radiotherapy, PUVA,
corticosteroids, IFN, low dose methotrexate, retinoids, Ontak

- CNS disease permitted

Exclusion Criteria:

- Pregnant or Nursing

- prior Alemtuzumab

- history of active Hep C

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity and safety of concurrent CHOP and Alemtuzumab

Outcome Time Frame:

up to five years

Safety Issue:


Principal Investigator

Pierluigi Porcu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Untreated
  • CD-20 Negative
  • Large B-Cell Lymphomas
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Extranodal NK-T-Cell



Ohio State University Columbus, Ohio  43210