Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

The purposes of this trial are: 1. 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. 2. 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. 3. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous infusion followed by a subcutaneous injection.


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.


Study is Available At:


Original ID:

ID02-424


NCT ID:

NCT00102661


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alessandra Ferrajoli, M.D.
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:October 2002
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:September 2006
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:July 27, 2012
First Received Date:January 31, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Response Rate (CR+PR) to CAMPATH-1H
Time Frame:3 months
Safety Issues:False
Description:Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.

Study Interventions

Intervention Type:Drug
Name:Campath-1H
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.
Arm Name:CAMPATH-1H
Other Name:Alemtuzumab

Study Arms

Study Arm Type:Experimental
Arm Name:CAMPATH-1H
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Berlex Laboratories, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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