NCT00021983

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1998

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

December 12, 2003

Completed
Last Updated

April 29, 2015

Status Verified

January 1, 2006

First QC Date

August 10, 2001

Last Update Submit

April 28, 2015

Conditions

Leukemia

Keywords

refractory hairy cell leukemia

Interventions

BL22 immunotoxinBIOLOGICAL

Eligibility Criteria

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

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 Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (3)

  • 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: 18596230BACKGROUND

  • Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1.

    PMID: 16061911BACKGROUND

  • Kreitman RJ, Wilson WH, Bergeron K, Raggio M, Stetler-Stevenson M, FitzGerald DJ, Pastan I. Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N Engl J Med. 2001 Jul 26;345(4):241-7. doi: 10.1056/NEJM200107263450402.

    PMID: 11474661RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Hairy Cell

Interventions

RFB4(dsFv)-PE38 recombinant immunotoxin

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 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 10, 2001

First Posted

December 12, 2003

Study Start

December 1, 1998

Last Updated

April 29, 2015

Record last verified: 2006-01

Locations

US(1)