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


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


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).


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.


Patients receive LMB-2 immunotoxin intravenously (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 up every 3 - 12 months.

Eligibility Criteria

Inclusion Criteria:

No anti-CD25 monoclonal antibody therapy within 12 weeks of enrollment

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 ug/mL of LMB-2 using a bioassay

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

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

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)

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

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 with a diffusing capacity of the lung for carbon monoxide (DLCO) < 55% of normal or a forced expiratory volume in one second (FEV1) < 60% of normal, based on either NIH or United States (USA) normal ranges

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 who have an active 2nd malignancy requiring systemic treatment

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



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.