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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00074048
First received: December 10, 2003
Last updated: June 17, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: BL22
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Response rate [ Time Frame: After even cycle numbers (2,4,6,8,10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2003
Study Completion Date: July 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BL22 immunotoxin
Drug: BL22
Dosing via IV on Days 1,3, and 5.

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074048

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Chair: Robert Kreitman, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radhika Parikh, MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00074048     History of Changes
Obsolete Identifiers: NCT00071318
Other Study ID Numbers: CDR0000341680, NCI-04-C-0014, NCI-6048
Study First Received: December 10, 2003
Last Updated: June 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
refractory hairy cell leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunotoxins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014