Completed

Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Hematologic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma. * Determine the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug, including the terminal elimination serum half-life, area under the curve, volume of distribution, and relationship to disease burden, in these patients. Secondary * Evaluate the immonogenicity of this drug in these patients. * Determine response in patients treated with this drug. * Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. 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, neutralizing antibodies (i.e., > 75% of the activity of 1 µg/mL of LMB-2 immunotoxin), or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR. Patients with acute lymphoblastic leukemia also receive cytarabine and hydrocortisone intrathecally once monthly concurrent with restaging lumbar punctures. Cohorts of 3-6 patients receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 12 patients are treated at that dose level. Patients are followed weekly for 1 month and then monthly thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 2-4 years.

Official TitlePediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas 
NCT00082004NCT00085150
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Non-Hodgkin's lymphoma, including the following subtypes: * Lymphoblastic lymphoma * Burkitt's lymphoma * Large cell lymphoma * Adult T-cell leukemia/lymphoma * Cutaneous T-cell lymphoma * Peripheral T-cell lymphoma * Hodgkin's disease * Acute myeloid leukemia * Chronic myelogenous leukemia * Acute lymphoblastic leukemia (ALL) * More than 5% blasts in the bone marrow (i.e., M2 marrow classification) * Acute hybrid leukemia, including the following subtypes: * Mixed lineage leukemia * Biphenotypic leukemia * Undifferentiated leukemia * CD25-positive (CD25+) disease, meeting 1 of the following criteria: * More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody * More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis * Measurable or evaluable disease * Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen * No available alternative curative therapies * Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor * No CNS leukemia or lymphoma, as evidenced by any of the following criteria: * Cerebrospinal fluid (CSF) WBC \> 5/µl AND confirmation of CSF blasts * Cranial neuropathies secondary to underlying malignancy * CNS lymphoma detected by radiological imaging * Prior CNS involvement with no current evidence of CNS malignancy allowed * No isolated testicular ALL PATIENT CHARACTERISTICS: Age * 6 months to 21 years Performance status * ECOG 0-3 (≥ 12 years of age) * Lansky 40-100% (\< 12 years of age) Life expectancy * Not specified Hematopoietic * Pancytopenia due to disease allowed * For patients without bone marrow involvement: * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 50,000/mm\^3 (transfusion independent) Hepatic * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 5 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine clearance ≥ 60 mL/min OR * Creatinine, meeting the following age-related criteria: * ≤ 0.8 mg/dL (≤ 5 years of age) * ≤ 1.0 mg/dL (6 to 10 years of age) * ≤ 1.2 mg/dL (11 to 15 years of age) * ≤ 1.5 mg/dL (\> 15 years of age) * Calcium 2.0-2.9 mmol/L Cardiovascular * Ejection fraction ≥ 45% by MUGA OR * Shortening fraction ≥ 28% by echocardiogram Pulmonary * Oxygen saturation ≥ 90% Other * Sodium 130-150 mmol/L * Potassium 3.0-5.5 mmol/L * Magnesium 0.5-1.23 mmol/L * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant unrelated systemic illness that would preclude study participation * No conditions that would preclude study compliance * No serum that neutralizes \> 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies) * No active graft-vs-host disease (i.e., off immunosuppression) PRIOR CONCURRENT THERAPY: Biologic therapy * Prior autologous bone marrow transplantation (BMT) allowed * At least 100 days since prior allogeneic BMT * At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) Chemotherapy * At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy * No other concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment * Tapering or discontinuation of steroids allowed Radiotherapy * At least 3 weeks since prior radiotherapy unless \< 10% of marrow is irradiated and measurable disease exists outside the radiation port Surgery * Not specified Other * Recovered from all prior therapy * At least 30 days since prior investigational agents * Concurrent oral supplementation to maintain normal electrolyte levels allowed * No concurrent anticoagulation therapy for disease-related conditions * No other concurrent investigational agents

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Winship Cancer Institute of Emory University

Atlanta, United StatesSee the location
Suspended

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States
Suspended

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, United States
Suspended

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, United States
Completed5 Study Centers