Campath Maintenance in Chronic Lymphocytic Leukemia

• Sponsor: Northwell Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00587847
• Collaborator: Bayer (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 51
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: Campath	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Drug: Campath; Campath 30 mg administered subcutaneously at varying intervals for up to 1 year; Other Names: Alemtuzumab

Outcome Measures

Primary Outcome Measures

1. Time to Progression (Months) [Every 8 weeks]

   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.

Secondary Outcome Measures

1. Rate of Infections [Weekly then every 2 weeks then every 3 weeks]

   Number of participants who developed clinical or laboratory evidence of infection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040

Sponsors and Collaborators

• Northwell Health
• Bayer

Investigators

• Principal Investigator: Kanti R. Rai, MD, Long Island Jewish Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kanti Rai, MD, Principal Investigator, Northwell Health
• ClinicalTrials.gov Identifier: NCT00587847
• Other Study ID Numbers: 05.10.030; Berlex Study# 106.0621
• First Posted: Jan 8, 2008
• Last Update Posted: Oct 15, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Kanti Rai, MD, Principal Investigator, Northwell Health: leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Alemtuzumab

Study Results

Participant Flow

Recruitment Details	The study was originally designed to recruit 20 patients but only 12 subjects were accrued to the trial before it was stopped due to poor recruitment. Subjects were entered between August 2005 and July 2007. All subjects had Chronic Lymphocytic Leukemia that was previously treated with chemotherapy.

Arm/Group Title	Single Arm, Open Label Trial.
Arm/Group Description	single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Period Title: Overall Study
STARTED	12
COMPLETED	5
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Single Arm, Open Label Trial.
Arm/Group Description	single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 50%
>=65 years	6 50%
Sex: Female, Male (Count of Participants)
Female	3 25%
Male	9 75%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Time to Progression (Months)
Description	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.
Time Frame	Every 8 weeks

Outcome Measure Data

Analysis Population Description

All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.

Arm/Group Title	Single Arm, Open Label Trial.
Arm/Group Description	single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
Measure Participants	12
Mean (Full Range) [months]	10

2. Secondary Outcome

Title	Rate of Infections
Description	Number of participants who developed clinical or laboratory evidence of infection.
Time Frame	Weekly then every 2 weeks then every 3 weeks

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of alemtuzumab were analyzed for safety.

Arm/Group Title	All Participants
Arm/Group Description	All participants were included in the safety analysis.
Measure Participants	12
Number [participants]	2 16.7%

Adverse Events

Arm/Group Title	Single Arm, Open Label Trial.
Arm/Group Description	single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
All Cause Mortality
	Single Arm, Open Label Trial.
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm, Open Label Trial.
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm, Open Label Trial.
	Affected / at Risk (%)	# Events
Total	5/12 (41.7%)
General disorders
Injection Site reaction	2/12 (16.7%)	2
Immune system disorders
Autoimmune disorder	2/12 (16.7%)	2
Infections and infestations
Lung infection	1/12 (8.3%)	1

Limitations/Caveats

Trial was terminated early due to poor accrual.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.