Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)
NCT00004101CI-TRIAL-00009414completedPhase 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)
Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
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 |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.
- interventionNames
- Biological: apolizumab
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment * At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR at least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present * Measurable or evaluable disease * Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only) * Not eligible for curative conventional therapy PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * Life expectancy: At least 3 months * Platelet count at least 75,000/mm3 * Bilirubin less than 2.5 mg/dL * SGOT less than 3 times upper limit of normal * Creatinine less than 2.0 mg/dL * No New York Heart Association class III or IV heart disease * No clinically significant pulmonary disease * No active serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior interferon * Concurrent transfusions allowed * At least 4 weeks since prior cytotoxic chemotherapy * No concurrent antineoplastic agents * At least 4 weeks since prior corticosteroids * No concurrent glucocorticoids * At least 4 weeks since prior radiotherapy
References
Publications (1)
- RESULTLink BK, Wang H, Byrd JC, et al.: Phase I trial of humanized 1D10 (Hu1D10) monoclonal anitbody class II molecules in patients with relapsed lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A86, 2000.