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Immunotoxin

LMB-2 for Hairy Cell Leukemia

Phase 2

Waitlist Available

Led By Robert J Kreitman, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months

Awards & highlights

Study Summary

This trial is studying a drug called LMB-2 to see if it is safe and effective in treating patients with hairy cell leukemia whose cancer cells contain a protein called CD25.

Eligible Conditions

Hairy Cell Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients Who Obtain Partial Response/Complete Remission

Secondary outcome measures

Duration of Response

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Side effects data

From 2022 Phase 2 trial • 15 Patients • NCT00321555

60%

Hypoalbuminemia

47%

Edema limbs

33%

Nausea

33%

Anemia

33%

Aspartate aminotransferase increased

33%

Lymphocyte count decreased

33%

Hyponatremia

27%

Platelet count decreased

27%

Alanine aminotransferase increased

27%

Weight gain

27%

Myalgia

27%

Headache

20%

Neutrophil count decreased

20%

Fatigue

20%

Dyspnea

20%

Fever

13%

Abdominal distension

13%

Pruritus

13%

Pain in extremity

13%

White blood cell decreased

13%

Back pain

13%

Death NOS

13%

Vomiting

13%

Edema face

13%

Cough

13%

Haptoglobin decreased

13%

Hyperglycemia

13%

Hyperkalemia

Dyspepsia

Proteinuria

Syncope

Vascular disorders - Other, Vascular leak syndrome

Vasovagal reaction

Pain

Bone pain

Dizziness

Capillary leak syndrome

Epistaxis

Allergic reaction

Chills

Febrile neutropenia

Atrial fibrillation

Urticaria

Hypokalemia

Allergic rhinitis

Confusion

Non-cardiac chest pain

CD4 lymphocytes decreased

Creatinine increased

Hypocalcemia

Blood bilirubin increased

Diarrhea

Upper respiratory infection

Anorexia

Constipation

Hypomagnesemia

Anaphylaxis

Hematuria

Hemoglobinuria

Hypermagnesemia

Hypertension

Hypotension

Hypoxia

Insomnia

Investigations - Other, Bicarbonate serum low

Left ventricular systolic dysfunction

Palpitations

Paroxysmal atrial tachycardia

Pericardial effusion

Peripheral sensory neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

LMB-2 to Treat Hairy Cell Leukemia

Trial Design

1Treatment groups

Experimental Treatment

Group I: LMB-2 to Treat Hairy Cell LeukemiaExperimental Treatment1 Intervention

LMB-2 Infusion: 40 micro-g/Kg will be infused in 50 ml of 0.9% Sodium chloride (NaCl) and 0.2% albumin via over 30 minutes every other day for 3 doses. Patients may receive up to six treatment cycles every 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin

2006

Completed Phase 2

~20

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Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,717 Previous Clinical Trials

40,953,299 Total Patients Enrolled

Robert J Kreitman, M.D.Principal InvestigatorNational Cancer Institute (NCI)

12 Previous Clinical Trials

2,214 Total Patients Enrolled

~1 spots leftby Jun 2025

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