BL22 Immunotoxin in Treating Patients Previously Treated With Cladribine for Hairy Cell Leukemia

June 17, 2010 updated by: MedImmune LLC

Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia

RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia that has not responded to treatment with cladribine.

PURPOSE: This phase II trial is studying BL22 immunotoxin to see how well it works in treating patients previously treated with cladribine for hairy cell leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin.

Secondary

  • Determine the response duration in patients treated with this drug.
  • Determine the safety of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients.

OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest.

Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR without minimal residual disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses beyond CR.

Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed hairy cell leukemia
  • CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody

  • Meets at least 1 of the following indications for treatment:

    • Absolute neutrophil count less than 1,000/mm^3
    • Hemoglobin less than 10 g/dL
    • Platelet count less than 100,000/mm^3
    • Absolute lymphocyte count greater than 20,000/mm^3
    • Symptomatic splenomegaly

  • Meets 1 of the following response criteria:

    • No response
    • Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine
    • CR or PR less than 4 years in duration after a second or later course of prior cladribine

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 2.2 mg/dL
  • Albumin at least 3.0 g/dL

Renal

  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness that would preclude study participation
  • Understand and give informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior BL22 immunotoxin
  • More than 12 weeks since prior monoclonal antibody therapy

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior systemic cytotoxic chemotherapy

Endocrine therapy

  • More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day)

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
BL22 immunotoxin
Drug: BL22
Dosing via IV on Days 1,3, and 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: After even cycle numbers (2,4,6,8,10)
After even cycle numbers (2,4,6,8,10)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]
Time Frame: 30 days after last dose of study drug
30 days after last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 10, 2003

First Submitted That Met QC Criteria

December 10, 2003

First Posted (Estimate)

December 11, 2003

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 17, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000341680
  • NCI-04-C-0014
  • NCI-6048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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