Clinical trial · Interventional
LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma
Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas
NCT00085150CI-TRIAL-00017728completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LMB-2 immunotoxin | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.