Campath Maintenance in Chronic Lymphocytic Leukemia

Northwell Health

Status: Terminated

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Campath

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00587847

05.10.030

Berlex Study# 106.0621 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Campath maintenance treatment

Other group

Description:

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.

Treatment:

Drug: Campath