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Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

NCT00051701•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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.
+5 more criteria

Locations (17)

Aurora, Colorado, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Indianapolis, Indiana, United States

Overland Park, Kansas, United States

Minneapolis, Minnesota, United States

Kansas City, Missouri, United States

Santa Fe, New Mexico, United States

Dayton, Ohio, United States

Tulsa, Oklahoma, United States

Key Dates

Start Date

December 1, 2002

Completion Date

August 1, 2005

Last Updated

March 5, 2015

Enrollment

Estimated participants

Conditions

Non-Hodgkins Lymphoma

Interventions

alemtuzumab

DRUG

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Resiliency in Older Adults Undergoing Bone Marrow Transplant

Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.

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