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

Genzyme

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Non-Hodgkins Lymphoma

Treatments

Drug: alemtuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051701

CAM.NHL232

BLA 99-0786

Details and patient eligibility

About

The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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) positive.
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.