Clinical trial · Interventional
Campath Maintenance in Chronic Lymphocytic Leukemia
Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
NCT00587847CI-TRIAL-00019482terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient recruitment.
Summary
Brief summary (as posted)
This is a study designed to test whether giving campath (also known as alemtuzumab) on a maintenance schedule will prolong the time until the patient requires chemotherapy.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Campath | Drug | Alemtuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Campath maintenance treatment
- description
- Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks.
- interventionNames
- Drug: Campath
Primary outcomes (1)
- measure
- Time to Progression (Months)
- timeFrame
- Every 8 weeks
- description
- Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Enrollment in this study is open to patients 18 years of age with confirmed chronic lymphocytic leukemia, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2 Exclusion Criteria: * Treatment failure in more than 3 prior regimens * Active secondary malignancy * Central nervous system involvement with CLL * History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy * History of HIV positivity * Hepatitis C virus (HCV) positivity based upon core antigen testing * Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents * Pregnancy or lactation * Other severe, concurrent diseases or mental disorders
References
Publications (0)
Data not yet available
No reference posted for this study.