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Anti-tumor antibiotic

LMB-2 + Fludarabine + Cyclophosphamide for Adult T-Cell Leukemia

Q: What is the capacity of this experimental program?

Unfortunately, this research project is not currently accepting new participants. It was first announced on October 31st 2008 and last updated on January 13th 2022. For those seeking alternative studies, there are 1,417 active trials for adult t cell <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> (ATL) and 889 clinical investigations related to LMB-2 that are recruiting patients right now.

Q: Who is eligible for enrollment in this experiment?

The eligible participants must have adult t cell <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> (ATL) and be between 18 to 100 years old. Currently, the trial is recruiting around 18 patients.

Q: Are recruitments still ongoing for this research endeavor?

This clinical trial has now ceased recruitment. It was originally posted on October 31st 2008, before being updated for the last time on January 13th 2022. Fortunately, there are thousands of studies that may still be recruiting; 1417 pertaining to adult T-cell <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> (ATL) and 889 related to LMB-2.

Q: Is this experiment open to participants aged 20 and over?

This medical experiment is recruiting individuals aged 18 years and above, but below 100.

Q: What indications are traditionally treated with LMB-2?

LMB-2 has demonstrated efficacy in treating <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> as well as various malignancies, including but not limited to <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic and retinoblastoma.

Q: Has LMB-2 previously been subjected to any research studies?

Presently, 889 research studies on LMB-2 are in progress. Of those trials, 161 have progressed to the Phase 3 stage. Trials for this treatment are primarily based in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>; however, 28443 sites across the country offer clinical trial access.

Phase 1 & 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 70 months

Awards & highlights

Study Summary

This trial is testing the safety of a new cancer treatment that uses a combination of drugs to attack leukemia cells. The treatment consists of a chemotherapy drug, a monoclonal antibody, and a recombinant immunotoxin. The goal of the trial is to determine if the treatment is effective in reducing the tumor size in patients with leukemia.

Eligible Conditions

Adult T Cell Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 70 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~70 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 70 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

Percentage of Participants With a Minimally Durable Clinical Response Rate

Secondary outcome measures

Area Under the Plasma Concentration (AUC) - LMB2

Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2

Cyclophosphamide

+12 more

Side effects data

From 2011 Phase 2 trial • 15 Patients • NCT00077922

93%

Albumin, serum-low (hypoalbuminemia)

75%

Magnesium, serum-high (hypermagnesemia)

73%

AST, SGOT(serum glutamic oxaloacetic transaminase)

73%

Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)

67%

Edema: limb

60%

Weight gain

60%

Hemoglobin

53%

Magnesium, serum-low (hypomagnesemia)

53%

Neutrophils/granulocytes (ANC/AG)

47%

Phosphate, serum-high (hyperphosphatemia)

47%

Glucose, serum-high (hyperglycemia)

47%

Fatigue (asthenia, lethargy, malaise)

47%

Pain::Head/headache

47%

Acute vascular leak syndrome

47%

Platelets

47%

Sodium, serum-low (hyponatremia)

40%

Alkaline phosphatase

40%

Edema::head and neck

40%

Pain::Muscle

40%

Cough

40%

Nausea

40%

Hemorrhage, GU: Urinary NOS

40%

Dizziness

33%

Bilirubin (hyperbilirubinemia)

33%

Bruising (in absence of Grade 3 or 4 thrombocytopenia)

33%

Pleural effusion (non-malignant)

33%

Potassium, serum-low (hypokalemia)

33%

Sodium, serum-high (hypernatremia)

27%

Vomiting

27%

Potassium, serum-high (hyperkalemia)

27%

Creatinine

27%

ALT, SGPT (serum glutamic pyruvic transaminase)

27%

Dyspnea (shortness of breath)

20%

GGT (gamma-Glutamyl transpeptidase)

20%

Rigors/chills

20%

Glucose, serum-low (hypoglycemia)

20%

Insomnia

20%

CPK (creatine phosphokinase)

20%

Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)

20%

Amylase

20%

Hemoglobinuria

20%

Diarrhea

20%

Constipation

20%

Supraventricular and nodal arrhythmia::Sinus tachycardia

20%

Hypotension

20%

Pericardial effusion (non-malignant)

20%

Calcium, serum-low (hypocalcemia)

20%

Proteinuria

20%

Triglyceride, serum-high (hypertriglyceridemia)

20%

Uric acid, serum-high (hyperuricemia)

13%

Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus

13%

Infection (documented clinically or microbiologically)

13%

Lipase

13%

Hypoxia

13%

Sweating (diaphoresis)

13%

Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS

13%

Rash/desquamation

13%

Dry eye syndrome

13%

haptoglobin

13%

Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral

13%

Bicarbonate, serum low

13%

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)

13%

Pain: Back

13%

Dysphagia (difficulty swallowing)

13%

Pain::Neuralgia/peripheral nerve

13%

Pain::Oral cavity

13%

Atelectasis

13%

Heartburn/dyspepsia

13%

Thyroid function, low (hypothyroidism)

13%

Anorexia

13%

Ocular surface disease

13%

Pain::Chest wall

13%

Urinary frequency/urgency

13%

Flu-like symptoms

13%

Hemorrhage, pulmonary/upper respiratory: Nose

13%

Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)

13%

Cholesterol, serum-high (hypercholesteremia)

CNS cerebrovascular ischemia

Tremor

Allergic reaction/hypersensitivity (including drug fever)

PTT (Partial Thromboplastin Time)

Dry skin

Bladder spasms

Obstruction, GU: Ureter

Weight loss

Pain::Eye

Ulceration

Hemorrhage, GI::Oral cavity

Confusion

Neuropathy:sensory

Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)

Hemorrhage, GU: Bladder

Neurology-Other (Specify, dizziness)

fibrinogen

Cardiac-ischemia/infarction

Ocular/Visual-Other (Specify, blindness r/t CVA)

Cardiac troponin I (cTnI)

Speech impairment (e.g., dysphasia or aphasia)

Infection

Dermatology/Skin - Other (Specify)

Pain: Abdomen NOS

Distension/bloating, abdominal

Pain::Middle ear

Pain::Neck

Pain::Throat/pharynx/larynx

Rash: hand-foot skin reaction

Dehydration

Vision-blurred vision

Pain - Other (Specify, extremity, limb)

Pain::Bone

Pain::Dental/teeth/peridontal

Pain: Extremity-limb

Pneumonitis/pulmonary infiltrates

Phlebitis (including superficial thrombosis)

Thrombosis/embolism (vascular access-related)

Thrombosis/thrombus/embolism

Leukocytes (total WBC)

Mucositis/stomatitis (clinical exam)::Oral cavity

Taste alteration (dysgeusia)

Hemorrhage, pulmonary/upper respiratory: Lung

Febrile neutropenia

Calcium, serum-high (hypercalcemia)

Mood alteration::Anxiety

Mood alteration::Depression

100%

80%

60%

40%

20%

Study treatment Arm

LMB-2 in Chronic Lymphocytic Leukemia

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fludarabine and Cyclophosphamide/LMB-2Experimental Treatment3 Interventions

Administer cycle 1 with Fludarabine and Cyclophosphamide (FC) alone. Two weeks after starting cycle 1, begin up to 6 cycles of FC plus LMB-2 at minimum 20-day intervals.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

LMB-2

2004

Completed Phase 2

~50

Fludarabine

2012

Completed Phase 3

~1080

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,353 Total Patients Enrolled

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

12 Previous Clinical Trials

2,211 Total Patients Enrolled

Media Library

Cyclophosphamide (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00924170 — Phase 1 & 2

Adult T Cell Leukemia Research Study Groups: Fludarabine and Cyclophosphamide/LMB-2

Adult T Cell Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00924170 — Phase 1 & 2

Cyclophosphamide (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00924170 — Phase 1 & 2

Frequently Asked Questions

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

What is the capacity of this experimental program?

"Unfortunately, this research project is not currently accepting new participants. It was first announced on October 31st 2008 and last updated on January 13th 2022. For those seeking alternative studies, there are 1,417 active trials for adult t cell leukemia (ATL) and 889 clinical investigations related to LMB-2 that are recruiting patients right now."

Answered by AI

Who is eligible for enrollment in this experiment?

"The eligible participants must have adult t cell leukemia (ATL) and be between 18 to 100 years old. Currently, the trial is recruiting around 18 patients."

Answered by AI

Are recruitments still ongoing for this research endeavor?

"This clinical trial has now ceased recruitment. It was originally posted on October 31st 2008, before being updated for the last time on January 13th 2022. Fortunately, there are thousands of studies that may still be recruiting; 1417 pertaining to adult T-cell leukemia (ATL) and 889 related to LMB-2."

Answered by AI

Is this experiment open to participants aged 20 and over?

"This medical experiment is recruiting individuals aged 18 years and above, but below 100."

Answered by AI

What indications are traditionally treated with LMB-2?

"LMB-2 has demonstrated efficacy in treating multiple sclerosis as well as various malignancies, including but not limited to lymphoma, leukemia, myelocytic and retinoblastoma."

Answered by AI

Has LMB-2 previously been subjected to any research studies?

"Presently, 889 research studies on LMB-2 are in progress. Of those trials, 161 have progressed to the Phase 3 stage. Trials for this treatment are primarily based in Philadelphia, Pennsylvania; however, 28443 sites across the country offer clinical trial access."

Answered by AI

Recent research and studies

Journal of Clinical InvestigationJournal

Functional and Phenotypic Comparison of Human T Cell Leukemia/lymphoma Virus Positive Adult T Cell Leukemia with Human T Cell Leukemia/lymphoma Virus Negative Sézary Leukemia, and Their Distinction Using Anti-tac. Monoclonal Antibody Identifying the Human Receptor for T Cell Growth Factor.

Waldmann, T A, W C Greene, P S Sarin, C Saxinger, D W Blayney, W A Blattner, C K Goldman, K Bongiovanni, S Sharrow, and J M Depper. 1984. “Functional and Phenotypic Comparison of Human T Cell Leukemia/lymphoma Virus Positive Adult T Cell Leukemia with Human T Cell Leukemia/lymphoma Virus Negative Sézary Leukemia, and Their Distinction Using Anti-tac. Monoclonal Antibody Identifying the Human Receptor for T Cell Growth Factor.”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci111379.

NatureJournal

A Monoclonal Antibody That Appears to Recognize the Receptor for Human T-cell Growth Factor; Partial Characterization of the Receptor

Leonard, Warren J., Joel M. Depper, Takashi Uchiyama, Kendall A. Smith, Thomas A. Waldmann, and Warner C. Greene. 1982. “A Monoclonal Antibody That Appears to Recognize the Receptor for Human T-cell Growth Factor; Partial Characterization of the Receptor”. Nature. Springer Science and Business Media LLC. doi:10.1038/300267a0.

OncogeneJournal

Global Epidemiology of HTLV-I Infection and Associated Diseases

Proietti, Fernando A, Anna Bárbara F Carneiro-Proietti, Bernadette C Catalan-Soares, and Edward L Murphy. 2005. “Global Epidemiology of HTLV-I Infection and Associated Diseases”. Oncogene. Springer Science and Business Media LLC. doi:10.1038/sj.onc.1208968.

Clinical Cancer ResearchJournal