Clinical trial · Interventional
Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia
Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas
NCT00021983CI-TRIAL-00017700completedPhase 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: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia. PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BL22 immunotoxin | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed refractory or recurrent hairy cell leukemia
* Relapsed after less than 2 years of complete remission after purine analog therapy
* Must have at least one of the following indications for therapy:
* Progressive or massive splenomegaly
* Cytopenia defined by the following:
* Absolute neutrophil count less than 1,000/mm\^3 OR
* Platelet count less than 100,000/mm\^3 OR
* Hemoglobin less than 12 g/dL
* More than 20,000 hairy cells/mm\^3
* Symptomatic adenopathy
* Constitutional symptoms including tumor-related fever or bone pain
* Evidence of CD22 positivity by 1 of the following:
* More than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry
* More than 30% of malignant cells from a site CD22+ by fluorescent-activated cell sorter
* More than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding
* No CNS disease requiring treatment
* No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies
* No patients whose serum neutralizes more than 75% of the activity of 1 microgram/mL of BL22 immunotoxin
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 6 months
Hematopoietic:
* See Disease Characteristics
* Pancytopenia due to disease allowed
Hepatic:
* ALT and AST less than 2.5 times upper limit of normal (ULN)
* Bilirubin less than 1.5 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL
Pulmonary:
* FEV1 at least 60% of predicted
* DLCO at least 55% of predicted
Other:
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior bone marrow transplantation allowed
* At least 3 weeks since prior interferon for the malignancy
* More than 3 months since prior monoclonal antibody therapy (e.g., rituximab)
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior cytotoxic chemotherapy for the malignancy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior whole body electron beam radiotherapy for the malignancy
* Radiotherapy within the past 3 weeks allowed provided less than 10% of total bone marrow was treated and patient has measurable disease outside the radiation port
Surgery:
* Not specified
Other:
* At least 3 weeks since prior retinoids for the malignancy
* At least 3 weeks since any other prior systemic therapy for the malignancy
* No concurrent therapeutic warfarinReferences
Publications (3)
- 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, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1. PMID 16061911
- RESULTKreitman RJ, Wilson WH, Bergeron K, Raggio M, Stetler-Stevenson M, FitzGerald DJ, Pastan I. Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N Engl J Med. 2001 Jul 26;345(4):241-7. doi: 10.1056/NEJM200107263450402. PMID 11474661