Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

April 28, 2015 updated by: National Cancer Institute (NCI)

Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.

PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22+ hairy cell leukemia.
  • Define the pharmacokinetics of this drug, including the terminal elimination serum half-life area under the curve and volume of distribution, in these patients.
  • Evaluate the immunogenicity of this drug in these patients.
  • Determine the effect of this drug on various components of the circulating cellular immune system in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 courses in the absence of disease progression and sufficient neutralizing antibodies.

Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.

Study Type

Interventional

Phase

  • Phase 1

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 Studies Support

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 refractory or recurrent hairy cell leukemia

    • Relapsed after less than 2 years of complete remission after purine analog therapy

    • Must have at least one of the following indications for therapy:

      • Progressive or massive splenomegaly

      • Cytopenia defined by the following:

        • Absolute neutrophil count less than 1,000/mm^3 OR
        • Platelet count less than 100,000/mm^3 OR
        • Hemoglobin less than 12 g/dL
      • More than 20,000 hairy cells/mm^3
      • Symptomatic adenopathy
      • Constitutional symptoms including tumor-related fever or bone pain

  • Evidence of CD22 positivity by 1 of the following:

    • More than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry
    • More than 30% of malignant cells from a site CD22+ by fluorescent-activated cell sorter
    • More than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding
  • No CNS disease requiring treatment

  • No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies

    • No patients whose serum neutralizes more than 75% of the activity of 1 microgram/mL of BL22 immunotoxin

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 6 months

Hematopoietic:

  • See Disease Characteristics
  • Pancytopenia due to disease allowed

Hepatic:

  • ALT and AST less than 2.5 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Pulmonary:

  • FEV1 at least 60% of predicted
  • DLCO at least 55% of predicted

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior bone marrow transplantation allowed
  • At least 3 weeks since prior interferon for the malignancy
  • More than 3 months since prior monoclonal antibody therapy (e.g., rituximab)

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior cytotoxic chemotherapy for the malignancy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior whole body electron beam radiotherapy for the malignancy
  • Radiotherapy within the past 3 weeks allowed provided less than 10% of total bone marrow was treated and patient has measurable disease outside the radiation port

Surgery:

  • Not specified

Other:

  • At least 3 weeks since prior retinoids for the malignancy
  • At least 3 weeks since any other prior systemic therapy for the malignancy
  • No concurrent therapeutic warfarin

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

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

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

December 1, 1998

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

December 11, 2003

First Posted (Estimate)

December 12, 2003

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066835
  • NCI-99-C-0014
  • NCI-T98-0063

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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