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

Primary Purpose

Non-Hodgkins Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
alemtuzumab
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma focused on measuring Non-Hodgkins lymphoma, NHL, Campath, alemtuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 15, 2003
Last Updated
March 4, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00051701
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkins Lymphoma
Keywords
Non-Hodgkins lymphoma, NHL, Campath, alemtuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
alemtuzumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Aurora
State/Province
Colorado
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Santa Fe
State/Province
New Mexico
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Ft. Worth
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Tyler
State/Province
Texas
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Vancouver
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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