Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)
- 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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apolizumab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed relapsed or refractory grade I, II, or III non-Hodgkin's lymphoma (NHL), including follicular, small lymphocytic, or marginal zone/MALT lymphoma * Previously treated with radiotherapy, immunotherapy, and/or chemotherapy for NHL * Progression of disease or no response since last treatment for NHL * 1D10+ lymphoma by immunohistochemistry or flow cytometry * Bidimensionally measurable disease at least 2 cm in a single dimension * No CNS metastases * Circulating tumor cells no greater than 5,000/mm\^3 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 75,000/mm\^3 (unless disease related) * Neutrophil count at least 1,000/mm\^3 (unless disease related) * Hemoglobin greater than 8.0 g/dL Hepatic: * Bilirubin less than 2.5 mg/dL * SGOT less than 4 times upper limit of normal Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No clinically significant cardiac disease (New York Heart Association class III or IV) * No evidence of myocardial infarction or cardiac arrhythmia (unless surgically repaired) within the past 6 months Pulmonary: * No clinically significant pulmonary disease Other: * No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ * No significant psychiatric or CNS impairment * No active serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study * Negative anti-Hu1D10 antibody response (HAHA/HAMA) * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 4 weeks since prior interferon therapy * At least 3 months since prior immunotherapy * No prior monoclonal antibody Hu1D10 Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy: * At least 4 weeks since prior corticosteroids (more than 10 mg prednisone/day) * No concurrent corticosteroids at more than 10 mg prednisone/day for pre-existing diseases or adverse reactions Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior external beam radiotherapy * At least 3 months since prior radioimmunotherapy Surgery: * Not specified Other: * No other concurrent lymphoma therapy
References
Publications (0)
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