← Back to Search

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%

Pain in extremity

13%

Pruritus

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

Proteinuria

Bone pain

Vascular disorders - Other, Vascular leak syndrome

Syncope

Vasovagal reaction

Dyspepsia

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,652 Total Patients Enrolled

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

12 Previous Clinical Trials

2,213 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial still offer the opportunity for participants to join?

"By referring to the information provided on clinicaltrials.gov, it appears as though this particular study is not presently accepting participants. Initially posted in May 2006 and last updated April 2022, it does not appear that recruitment for this trial will resume at present. Yet there are over 1400 other studies recruiting patients now."

Answered by AI

How does the Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin affect patient safety?

"Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin has been assessed as a 2 on our safety scale since this is Phase 2 trial, indicating that there are some data confirming its safety but not any evidence of efficacy."

Answered by AI

Is this trial open to geriatric individuals?

"This research trial only admits individuals aged 18 to 100, with 428 studies available for minors and 1129 trials open to senior citizens."

Answered by AI

Who is eligible for participation in this medical trial?

"Admittance to this clinical trial requires leukemia and a patient age ranging from 18 years old up until the century mark. Currently, 15 individuals are sought for enrollment."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

Antileukemic and Immunosuppressive Activity of 2-chloro-2'-deoxyadenosine.

Carson, D A, D B Wasson, and E Beutler. 1984. “Antileukemic and Immunosuppressive Activity of 2-chloro-2'-deoxyadenosine.”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.81.7.2232.

Annals of Internal MedicineJournal

Clinical Trials in Hairy Cell Leukemia

CHESON, BRUCE D.. 1987. “Clinical Trials in Hairy Cell Leukemia”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-106-6-871.

Leukemia & LymphomaJournal

Hairy Cell Leukemia–variant Treated with 2-chlorodeoxyadenosine—a Report of Three Cases

Blasińska-Morawiec, M., T. Robak, E. Krykowski, A. Hellmann, and H. Urbańska-Ryś. 1997. “Hairy Cell Leukemia–variant Treated with 2-chlorodeoxyadenosine—a Report of Three Cases”. Leukemia & Lymphoma. Informa UK Limited. doi:10.3109/10428199709114177.

BloodJournal