Campath Maintenance in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00587847
• Other study ID #: 05.10.030
• Secondary ID: Berlex Study# 10
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: September 16, 2015
• Start date: August 2005
• Est. completion date: November 2009

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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

Locations

Country	Name	City	State
United States	Long Island Jewish Medical Center	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression (Months)	Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.	Every 8 weeks	No
Secondary	Rate of Infections	Number of participants who developed clinical or laboratory evidence of infection.	Weekly then every 2 weeks then every 3 weeks	Yes