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

Non-Hodgkins Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00051701
• Other study ID #: CAM.NHL232
• Secondary ID: BLA 99-0786
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 15, 2003
• Last updated: March 4, 2015
• Start date: December 2002
• Est. completion date: August 2005

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

Drug:
• alemtuzumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States,