Clinical trial · Interventional
Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to slow accrual.
Summary
Brief summary (as posted)
Primary Objective: To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma. Secondary Objectives: 1. To determine the duration of response and time to progression after Campath-1H therapy in this patient population. 2. To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients with relapsed and resistant classical Hodgkin's lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab (Campath-1H) | Drug | Alemtuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab
- interventionNames
- Drug: Alemtuzumab (Campath-1H)
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 1 Year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory Hodgkin's disease with a minimum of 2 prior treatment regimens, including autologous bone marrow transplantation. * Must have histologically proven diagnosis of nodular sclerosis or mixed cellularity Hodgkin's disease. * Hodgkin's lymphoma should be limited to lymph nodes, spleen, and bone marrow. * Must have bi-dimensionally measurable disease defined as a lymph node at least 2 cm by computed tomography (CT) scan. * Platelet count equal to or greater than 50,000/uL; absolute neutrophil count equal to or greater than 1,000/uL. * Must sign a consent form. * Males or females equal to or greater than 18 years of age. * Patients may be taking voriconazole, itraconazole, or diflucan. Exclusion Criteria: * No serious inter-current infections requiring therapy. * No Hodgkin-specific therapy within the last 3 weeks. * Pregnant women and women of childbearing potential and men of reproductive potential who are not practicing adequate contraception. * Lymphocyte depletion or lymphocyte predominance histology. * History of HIV infection. * Central nervous system (CNS) involvement with lymphoma including epidural disease and cord compression. * Prior allogeneic stem cell transplantation. * Patients receiving steroids within 3 weeks of registration. * Patients with a history of prior severe opportunistic infections that are controlled by T-cell immunity, such as pneumocystis pneumonia (PCP), herpes virus infections, mycobacterial disease, invasive mold infections or endemic fungi. * Patients with an ejection fraction of less than 40%.
References
Publications (0)
Data not yet available