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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Terminated

CT.gov ID

NCT00051701

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkins Lymphoma	Drug: alemtuzumab	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2002

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	Aurora	Colorado	United States
2	Colorado Springs	Colorado	United States
3	Denver	Colorado	United States
4	Indianapolis	Indiana	United States
5	Overland Park	Kansas	United States
6	Minneapolis	Minnesota	United States
7	Kansas City	Missouri	United States
8	Santa Fe	New Mexico	United States
9	Dayton	Ohio	United States
10	Tulsa	Oklahoma	United States
11	Dallas	Texas	United States
12	Ft. Worth	Texas	United States
13	Plano	Texas	United States
14	San Antonio	Texas	United States
15	Tyler	Texas	United States
16	Spokane	Washington	United States
17	Vancouver	Washington	United States