NCT00126646

Brief Summary

RATIONALE: BL22 immunotoxin can find tumor cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Jun 2005

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

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

3.8 years

First QC Date

August 2, 2005

Last Update Submit

June 17, 2010

Conditions

LeukemiaLymphoma

Keywords

B-cell chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomarecurrent mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomarecurrent adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomaWaldenstrom macroglobulinemiaprolymphocytic leukemia

Interventions

BL22 immunotoxinDRUG
antibody-drug conjugate therapyPROCEDURE
immunotoxin therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of B-cell leukemia or lymphoma of 1 of the following types: * Chronic lymphocytic leukemia * Failed standard chemotherapy * Prolymphocytic leukemia * Failed standard chemotherapy * Indolent non-Hodgkin's lymphoma, including mantle cell lymphoma * Stage III or IV disease * Failed ≥ 1 prior doxorubicin- or fludarabine-containing standard therapy * CD22-positive disease, as evidenced by 1 of the following: * More than 15% malignant cells react with anti-CD22 by immunohistochemistry * More than 30% malignant cells are CD22-positive by fluorescence-activated cell sorting analysis * More than 400 CD22 sites per malignant cell (average) by radiolabeled anti-CD22 binding * Treatment is medically indicated, as evidenced by any of the following: * Progressive disease-related symptoms * Progressive cytopenias due to marrow involvement * Progressive or painful splenomegaly or adenopathy * Rapidly increasing lymphocytosis * Autoimmune hemolytic anemia or thrombocytopenia * Increased frequency of infections * No neutralizing anti-toxin or anti-mouse immunoglobulin G (IgG) antibodies to BL22 or PE38 * No serum neutralization of \> 75% of the activity of 1 μg/mL of BL22 * No CNS disease requiring treatment * No hairy cell leukemia PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3\* * Platelet count \> 40,000/mm\^3 NOTE: \*Patients with leukemia are eligible regardless of absolute neutrophil count; Grade III-IV pancytopenia or growth factor dependence allowed if due to disease Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * ALT and AST \< 2.5 times ULN Renal * Creatinine ≤ 1.5 mg/dL Pulmonary * FEV1 ≥ 60% of predicted * DLCO ≥ 55% of predicted Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Prior bone marrow transplantation allowed * More than 3 weeks since prior biologic therapy, including interferon, denileukin diftitox, or LMB-2 immunotoxin * More than 3 months since prior monoclonal antibody therapy (e.g., rituximab) Chemotherapy * See Disease Characteristics * More than 3 weeks since prior cytotoxic chemotherapy Endocrine therapy * More than 1 week since prior steriods * Less than 5 doses for non-treatment reasons (e.g., allergy prophylaxis) * No evidence of disease response Radiotherapy * More than 3 weeks since prior whole-body electron beam radiotherapy * Radiotherapy within the past 3 weeks allowed provided the volume of bone marrow treated is \< 10% AND the patient has measurable disease located outside the radiation port Surgery * Not specified Other * More than 3 weeks since prior retinoids * More than 3 weeks since other prior systemic therapy for this malignancy

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)

  • 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: 16061911RESULT

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaLeukemia, Prolymphocytic

Interventions

RFB4(dsFv)-PE38 recombinant immunotoxin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Robert Kreitman, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

June 1, 2005

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

US(1)