Clinical trial · Interventional
Immunotoxin in Treating Patients With Leukemia or Lymphoma
PHASE I STUDY OF ANTI-TAC(Fv)-PE38 (LMB-2), A RECOMBINANT SINGLE-CHAIN IMMUNOTOXIN FOR TREATMENT OF TAC-EXPRESSING MALIGNANCIES
NCT00002765CI-TRIAL-00017687completedPhase 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: Immunotoxins can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of LMB-2 immunotoxin in treating patients who have 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
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed Hodgkin's disease, non-Hodgkin's lymphoma, or leukemia in one of the following categories:
* Adult T-cell leukemia or lymphoma (ATL)
* No smoldering ATL
* No limitation on prior therapy
* Cutaneous T-cell lymphoma (CTCL)
* Stages IB-III and failed at least 1 standard therapy
* Stage IV regardless of prior therapy
* Stages I-IV peripheral T-cell lymphoma
* Relapsed after standard chemotherapy
* Ineligible for or refused salvage chemotherapy or bone marrow transplantation (BMT)
* B-cell non-Hodgkin's lymphoma (NHL) of any histology
* Indolent stages II-IV NHL
* Failed at least 1 standard therapy
* Disease symptomatic and requiring treatment
* Aggressive NHL
* Relapsed after standard chemotherapy
* Ineligible for or refused salvage chemotherapy or BMT
* Chronic lymphocytic leukemia (CLL)
* Rai stages III and IV or Binet stage C
* Failed standard therapy and at least 1 salvage chemotherapy
* Primary B-cell prolymphocytic leukemia or prolymphocytic transformation of CLL
* Failed standard therapy and at least 1 salvage chemotherapy
* Hairy cell leukemia
* Failed standard and salvage chemotherapy
* Ineligible for or refused further salvage chemotherapy or BMT
* Acute myelogenous leukemia
* Failed standard chemotherapy
* Ineligible for or refused salvage chemotherapy or BMT
* Stages II-IV Hodgkin's disease
* Failed standard chemotherapy
* Ineligible for curative salvage radiotherapy or chemotherapy
* Ineligible for or refused BMT
* Patients with leukemias or lymphomas not easily classified in above categories who have failed standard therapy and are ineligible for or have refused bone marrow transplant
* Evidence of interleukin-2 receptor-alpha (IL2Ra) expression by one of the following:
* Greater than 10% of malignant cells reactive with anti-Tac by immunohistochemistry
* Greater than 10% of malignant cells from a particular site positive by FACS
* Greater than 400 IL2Ra sites per malignant cell by radiolabeled anti-Tac binding
* Soluble IL2Ra level greater than 1,000 U/mL (normal geometric mean 235, with 95% confidence levels of 112-502 U)
* Hodgkin's disease with measurable disease not amenable to biopsy
* No CNS disease requiring treatment
* Malignant cells in CSF allowed if judged not to represent clinically significant leukemic or lymphomatous meningitis (as in CSF contamination by blood)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 50-100%
Life expectancy:
* Greater than 2 months
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm3\*
* Platelet count greater than 50,000/mm3\* NOTE: \*nonleukemic patients
Hepatic:
* AST and ALT less than 5 times normal
Renal:
* Creatinine less than 2.0 mg/dL OR
* Creatinine clearance greater than 50 mL/min
Pulmonary:
* FEV1, TLC, and DLCO greater than 50% of predicted if pulmonary or mediastinal involvement with tumor greater than one third of total thoracic diameter
Other:
* HIV negative
* Not pregnant
* Fertile patients must use effective contraception
* Serum must neutralize no more than 75% LMB-2 in tissue culture
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 3 weeks since prior interferon
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior cytotoxic chemotherapy
* At least 3 weeks since prior retinoids
* No concurrent chemotherapy
Endocrine therapy:
* No concurrent corticosteroids unless begun at least 3 weeks prior to entry and dose not increased during 3 weeks prior to entry
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior whole-body electron beam radiotherapy
* Other radiotherapy allowed within 3 weeks of entry provided less than 10% of marrow irradiated and measurable disease exists outside radiation port
Surgery:
* Not specified
Other:
* See Disease Characteristics
* At least 3 weeks since any prior systemic therapy
* No other concurrent investigational agentsReferences
Publications (5)
- BACKGROUNDMatsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2. PMID 18596230
- BACKGROUNDKreitman RJ, Margulies I, Stetler-Stevenson M, Wang QC, FitzGerald DJ, Pastan I. Cytotoxic activity of disulfide-stabilized recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) toward fresh malignant cells from patients with B-cell leukemias. Clin Cancer Res. 2000 Apr;6(4):1476-87. PMID 10778980
- BACKGROUNDRobbins DH, Margulies I, Stetler-Stevenson M, Kreitman RJ. Hairy cell leukemia, a B-cell neoplasm that is particularly sensitive to the cytotoxic effect of anti-Tac(Fv)-PE38 (LMB-2). Clin Cancer Res. 2000 Feb;6(2):693-700. PMID 10690555
- RESULTKreitman RJ, Wilson WH, White JD, Stetler-Stevenson M, Jaffe ES, Giardina S, Waldmann TA, Pastan I. Phase I trial of recombinant immunotoxin anti-Tac(Fv)-PE38 (LMB-2) in patients with hematologic malignancies. J Clin Oncol. 2000 Apr;18(8):1622-36. doi: 10.1200/JCO.2000.18.8.1622. PMID 10764422
- RESULTKreitman RJ, Wilson WH, Robbins D, Margulies I, Stetler-Stevenson M, Waldmann TA, Pastan I. Responses in refractory hairy cell leukemia to a recombinant immunotoxin. Blood. 1999 Nov 15;94(10):3340-8. PMID 10552943