Campath Maintenance in Chronic Lymphocytic Leukemia

NCT ID: NCT00587847

Last Updated: 2015-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-11-30

Brief Summary

This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.

Detailed Description

This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Campath maintenance treatment

Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks.

Group Type: OTHER

Campath

Intervention Type: DRUG

Campath 30 mg administered subcutaneously at varying intervals for up to 1 year

Interventions

Campath

Campath 30 mg administered subcutaneously at varying intervals for up to 1 year

Intervention Type: DRUG

Other Intervention Names

Alemtuzumab

Eligibility Criteria

Inclusion Criteria

• Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria

• Treatment failure in more than 3 prior regimens
• Active secondary malignancy
• Central nervous system involvement with CLL
• History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
• History of HIV positivity
• Hepatitis C virus (HCV) positivity based upon core antigen testing
• Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
• Pregnancy or lactation
• Other severe, concurrent diseases or mental disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Kanti Rai, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kanti R. Rai, MD

Role: PRINCIPAL_INVESTIGATOR

Long Island Jewish Medical Center

Locations

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

Berlex Study# 106.0621

Identifier Type: OTHER

Identifier Source: secondary_id

05.10.030

Identifier Type: -

Identifier Source: org_study_id