LMB-2 Immunotoxin in Treating Patients with Hairy Cell Leukemia

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIBiomarker/Laboratory analysis, Treatment18 and over06-C-0150
NCI-2009-00231, CDR0000482415, NCT00337311, P6760, 7834, NCI-06-C-0150, NCI-P6760, NCI-7834, NCT00321555

Trial Description

Summary

This phase II trial studies how well anti-Tac(Fv)-PE38 (LMB-2) immunotoxin works in treating patients with hairy cell leukemia. The LMB-2 immunotoxin can find cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the response rate of LMB-2 (LMB-2 immunotoxin) in patients with cluster of differentiation (CD)25-positive hairy cell leukemia (HCL).

SECONDARY OBJECTIVES:

I. To describe the response duration.

II. To describe how blood levels of LMB-2 (area under curve [AUC], maximum concentration [Cmax]) are related to toxicity.

III. To describe how the development of neutralizing antibodies affects blood levels of LMB-2 and toxicity.

IV. To describe how soluble Tac-peptide (soluble interleukin-2 receptor alpha [sIL2Ra]) levels correlate with response to treatment with LMB-2.

OUTLINE:

Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional courses beyond CR. Patients achieving CR with minimal residual disease (MRD) may receive up to 4 additional courses beyond CR with MRD. Patients who relapse after > 2 months of a CR or partial response may be eligible for retreatment.

After completion of study treatment, patients are followed periodically.

Eligibility Criteria

Inclusion Criteria:

Patients should not have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients may not be receiving any other investigational agents

No prior treatment with LMB-2

No monoclonal antibody therapy within 12 weeks of enrollment

Creatinine =< 1.4 mg/dL or creatinine clearance >= 50 mL/min

Albumin >= 3.0 gm/dL

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 times upper limit of normal

Understand and give informed consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Previous treatment with or inability to receive BL22 recombinant immunotoxin; patients must have received cladribine with < 2 year complete response (CR)/partial response (PR) after their last course of primary cladribine therapy or < 4 year CR/PR after a 2nd or later course of cladribine

Absolute lymphocyte count of > 20,000 cells/ul or symptomatic splenomegaly

Thrombocytopenia (platelets [Plt] < 100,000/ul)

Anemia (hemoglobin [Hgb] < 10g/dL)

Neutropenia (absolute neutrophil count [ANC] < 1000 cells/ul)

At least one of the following indications for treatment:

Histopathological evidence of CD25+ HCL confirmed by the National Institutes of Health (NIH) pathology department; this will require a monoclonal population of peripheral malignant lymphocytes that are CD25 positive by fluorescence activated cell sorting (FACS) with anti-CD25 antibody; positive expression in a FACS assay is defined as more than 2 times the mean fluorescence intensity (MFI) of the control antibody by FACS; HCLv (HCL variant) is usually CD25 negative, and eligibility would require CD25+ HCLv

No systemic cytotoxic chemotherapy within 4 weeks of enrollment or systemic steroids (except stable doses of Prednisone =< 20 mg/day, or up to 4 doses of steroid given for non-therapy reasons) within 4 weeks of enrollment

Serum that neutralizes =< 75% of the activity of 1 μg/mL of LMB-2 using a bioassay

Total bilirubin =< 2.2 mg/dL

A negative pregnancy test in female patients of childbearing potential; women must not be breast-feeding

Exclusion Criteria:

Patients who have an active 2nd malignancy requiring systemic treatment

Patients with a diffusing capacity of the lung for carbon monoxide (DLCO) < 55% of normal or an forced expiratory volume in one second (FEV1) < 60% of normal

Patients receiving coumadin

Patients who have human immunodeficiency virus (HIV) or hepatitis C; patients would not be excluded for hepatitis B surface antigen positivity if on Lamivudine

Patients with a left ventricular ejection fraction of < 45%

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

National Cancer Institute

  • National Cancer Institute
Robert J. Kreitman, Principal Investigator

Trial Sites

U.S.A.

Maryland
Bethesda

Mark O Hatfield-Warren Grant Magnuson Clinical Center

Robert J. Kreitman
Ph: 301-496-6947
Email: kreitmar@mail.nih.gov

Robert J. Kreitman
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00321555

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.