Clinical trial · Interventional
Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
A Multicenter Phase II Evaluation Of ONTAK (DENILEUKINDIFTITOX) In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkin's Lymphoma Who Have Been Treated Previously With A Monoclonal Antibody Or Who Are Not Candidates For Monoclonal Antibody Therapy
- 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: Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to non-Hodgkin's lymphoma cells. PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's 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 |
|---|---|---|---|
| denileukin diftitox | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma (NHL) Working Formulation classification: Small lymphocytic lymphoma Follicular lymphoma (small cleaved or mixed small and large cell) REAL classification: B-cell chronic lymphocytic leukemia/small lymphocytic Lymphoplasmacytoid Marginal zone/MALT Follicular small or mixed small and large cell OR Histologically confirmed intermediate-grade B-cell NHL Working Formulation classification: Follicular large cell Diffuse small cleaved cell Diffuse mixed small and large cell Diffuse large cell REAL classification: Mantle cell Diffuse small cell Marginal zone/MALT Large B-cell Lymphoplasmacytoid Stage I, II, III, or IV disease No cutaneous T-cell lymphoma or other T-cell NHL Bidimensionally measurable disease Unidimensionally measurable disease allowed for mediastinal lymphoma only if outside previously irradiated field or there is evidence of progression Received prior monoclonal antibody therapy OR ineligible for monoclonal antibody therapy A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN Albumin at least 3.0 g/dL No chronic hepatitis Renal: Creatinine less than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No poorly controlled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious concurrent illness or active infection requiring parenteral antibiotics that would preclude study No known hypersensitivity to study drug or its components, including diphtheria toxin, interleukin-2, or excipients No other malignancy within the past 5 years except resected basal or squamous cell skin cancer or carcinoma in situ of the cervix (prostate cancer in situ or breast cancer in situ within the past 5 years is allowed if patients are in complete remission with no active disease, have stable tumor markers for at least 3 months, and have a life expectancy of at least 2 years) PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior bone marrow transplantation allowed No prior denileukin diftitox or DAB486 IL-2 No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent hormonal anticancer therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to sole site of disease unless evidence of progression No concurrent radiotherapy Surgery: Not specified Other: At least 1 month since prior investigational agent No other concurrent experimental medications, including approved drugs tested in an investigational setting
References
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