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Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Campath-1H
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age >= 18 years (CLL does not occur in the pediatric population). Signed informed consent. World Health Organization (WHO) performance status of 0, 1, or 2. Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible. Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells. Exclusion Criteria: Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies. Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start. Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception. Patients with history of HIV positivity. Active secondary malignancy. Active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAMPATH-1H

Arm Description

15 mg infused daily for continuous infusion x 7 days; starting day 10, CAMPATH-1H 30 mg subcutaneously three times weekly for 11 additional weeks.

Outcomes

Primary Outcome Measures

Response Rate (CR+PR) to CAMPATH-1H
Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2005
Last Updated
July 27, 2012
Sponsor
M.D. Anderson Cancer Center
Collaborators
Berlex Laboratories, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00102661
Brief Title
Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
Official Title
Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Berlex Laboratories, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (CLL) who have already received standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.
Detailed Description
The purposes of this trial are: To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion followed by subcutaneous injection in patients with previously treated CLL who have failed fludarabine therapy. To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous injections to patients with previously treated CLL will improve tolerability of the agent and permit higher doses to be delivered through that route. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous infusion followed by a subcutaneous injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAMPATH-1H
Arm Type
Experimental
Arm Description
15 mg infused daily for continuous infusion x 7 days; starting day 10, CAMPATH-1H 30 mg subcutaneously three times weekly for 11 additional weeks.
Intervention Type
Drug
Intervention Name(s)
Campath-1H
Other Intervention Name(s)
Alemtuzumab, Campath
Intervention Description
15 mg daily infused over 24 hours, continuous infusion x 7 days (Days 1 through 7). Each 15 mg dose prepared daily, immediately prior to starting the infusion. Starting day 10, CAMPATH-1H administered at dose of 30 mg subcutaneously three times weekly for 11 additional weeks.
Primary Outcome Measure Information:
Title
Response Rate (CR+PR) to CAMPATH-1H
Description
Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years (CLL does not occur in the pediatric population). Signed informed consent. World Health Organization (WHO) performance status of 0, 1, or 2. Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible. Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells. Exclusion Criteria: Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies. Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start. Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception. Patients with history of HIV positivity. Active secondary malignancy. Active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Ferrajoli, M.D.
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia

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