Campath Maintenance in Chronic Lymphocytic Leukemia

NCT00587847 | Terminated Results

• 2 other identifiers: 05.10.030Berlex Study# 106.0621
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rate of Infections

  Weekly then every 2 weeks then every 3 weeks

Study Arms (1)

Campath maintenance treatment

OTHER

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.

Drug: Campath

Interventions

Campath DRUG

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

Also known as: Alemtuzumab

Campath maintenance treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Bayer: collaborator

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Trial was terminated early due to poor accrual.

Results Point of Contact

• Title: Kanti Rai, MD
• Organization: North Shore-Long Island Jewish Health System

krai@nshs.edu

(718) 470-4050

Study Officials

• Kanti R. Rai, MD

  Long Island Jewish Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 8, 2008
• Study Start: August 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 15, 2015
• Results First Posted: October 15, 2015

Record last verified: 2015-09

Locations

US (1)