Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 10, 2001
Last updated: February 7, 2009
Last verified: January 2006

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.

Condition Intervention Phase
Biological: BL22 immunotoxin
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1998
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 6 months


  • See Disease Characteristics
  • Pancytopenia due to disease allowed


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


  • Creatinine no greater than 2.0 mg/dL


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


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


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)


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

Endocrine therapy:

  • Not specified


  • 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


  • Not specified


  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00021983

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Study Chair: Robert Kreitman, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications: Identifier: NCT00021983     History of Changes
Obsolete Identifiers: NCT00001792
Other Study ID Numbers: CDR0000066835, NCI-99-C-0014, NCI-T98-0063
Study First Received: August 10, 2001
Last Updated: February 7, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory hairy cell leukemia

Additional relevant MeSH terms:
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014