Clinical trial NCT00051701: Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
Official title: Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkins Lymphoma
Keywords: Non-Hodgkins lymphoma
NHL
Campath
alemtuzumab
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-01-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Santa Fe
country: United States
state: New Mexico
city: Dayton
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: