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Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Hodgkins Lymphoma

Thank you

Trial Information

Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma

This study is being conducted in 2 parts with the primary objective of part 1 being to
determine the maximum tolerated dose (MTD) of CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH)
administered intravenously (IV) once a week as treatment for relapsing or refractory
non-Hodgkin's lymphoma (NHL). The primary objective of part 2 is to determine the overall
response rate (complete response, CR/unconfirmed , plus partial response) of weekly IV
CAMPATH in the treatment of relapsing or refractory NHL. This is a Phase I/II study,
open-label, multicenter study to evaluate the efficacy and safety of weekly IV CAMPATH as
therapy for patients with relapsing or refractory non-Hodgkin's lymphoma.

Inclusion Criteria:

Patients must have:

- Pathologically confirmed diagnosis of relapsing or refractory non-Hodgkin's lymphoma
that has failed conventional therapy.

- Measurable disease (lesions that can be accurately measured by CT scan and a greatest
transverse diameter larger or equal to 1 cm or palpable lesions that both diameters
larger or equal to 2 cm).

- Life expectancy of at least 12 weeks. - World Health Organization (WHO) performance
status (PS) of 0, 1, or 2.

- Adequate marrow and organ function (details are listed in the protocol).

- Female patients with childbearing potential must have a negative serum pregnancy test
within 2 weeks prior to enrollment. Male and female patients must agree to use an
effective contraceptive method while on study treatment, if appropriate, and for a
minimum of 6 months following study therapy.

- Signed, written informed consent.

Exclusion Criteria: Patients must not have:

- Prior autologous bone marrow or stem cell transplant within 6 months of study entry.

- A history of prior allogeneic bone marrow transplant or organ transplant.

- Previously untreated non-Hodgkin's lymphoma.

- Previously treated with CAMPATH.

- Patients with bulky disease, ie any single mass > 7.5cm.

- Prior radiotherapy to the only site of measurable disease.

- Medical condition requiring chronic use of oral, high-dose corticosteroids.

- Autoimmune thrombocytopenia.

- Use of investigational agents within previous 30 days or any anti-cancer therapy
within the previous 3 weeks. Patients must have recovered from all acute toxicities
of any prior therapy.

- Past history of anaphylaxis following exposure to humanized monoclonal antibodies.

- Active, uncontrolled infection, including human immunodeficiency virus (HIV)

- Active secondary malignancy.

- Active central nervous system (CNS) involvement with NHL.

- Pregnant or lactating women. Male or female patients who do not agree to use
effective contraceptive method(s) during the study.

- Any significant concurrent disease or illness that would, in the opinion of the
investigator, compromise patient safety or compliance, or interfere with the
interpretation of study results.

Type of Study:


Study Design:

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

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

June 2005

Related Keywords:

  • Non-Hodgkins Lymphoma
  • Non-Hodgkins lymphoma
  • NHL
  • Campath
  • alemtuzumab
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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