NCT00074048

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

3.5 years

First QC Date

December 10, 2003

Last Update Submit

June 17, 2010

Conditions

Leukemia

Keywords

refractory hairy cell leukemia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    After even cycle numbers (2,4,6,8,10)

Secondary Outcomes (1)

  • Duration of Response: [Timeframe: Date that a response begins with the date that PD is documented.]

    30 days after last dose of study drug

Study Arms (1)

1

EXPERIMENTAL

BL22 immunotoxin

Drug: BL22

Interventions

BL22DRUG

Dosing via IV on Days 1,3, and 5.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.

    PMID: 18596230DERIVED

MeSH Terms

Conditions

LeukemiaLeukemia, Hairy Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Robert Kreitman, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

October 1, 2003

Primary Completion

April 1, 2007

Study Completion

July 1, 2008

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

US(1)