Clinical trial · Interventional
Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia
A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia
NCT01982175CI-TRIAL-00059203CLL004suspendedPhase 2ClinicalTrials.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): recruiting difficulties
Summary
Brief summary (as posted)
This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.
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 |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Biological | Alemtuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab
- description
- Patients receive Alemtuzumab escalated from initial dose of 3mg/day then 10mg/day and up to 30mg/day by intravenous infusion(if tolerated). when stable dose of 30mg/day is tolerated, Alemtuzumab is administrated at 30mg by IV infusion 3 times per week for up to 12 weeks (including escalation and stable dose period). After completion of 12 weeks treatment, or discontinuation of treatment within 12 weeks due to disease progression, patients will be visited every 3 months up to 1 year from enrollment or to death, whichever occurs first.
- interventionNames
- Biological: Alemtuzumab
Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- up to 1 year
- description
- Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR). ORR=CR+PR
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * An established diagnosis of B-cell chronic lymphocytic leukemia(B-CLL) * Meet criteria of relapsed or refractory CLL * Presence of one or more measurable lesions * ECOG Score 0-1 * Life expectancy \> 3 months * Female patients with childbearing potential must have a negative serum pregnancy test, male and female patients must agree to use an effective contraceptive method while on study treatment, and for a minimum 1 year following study therapy. Exclusion Criteria: * Less than 2 weeks from prior anti-cancer therapy. * Allergic to the antibody or any component of the investigational product. * Other severe, concurrent diseases, including mental disorders, serious cardiac functional capacity (Class III or IV), uncontrolled diabetes. * Use of investigational agents rather than Alemtuzumab. * Active systematic infection or major organ malfunction requiring treatment. * Serum total bilirubin greater than or equal to 1.5 times upper limits of normal; or Serum alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) greater than or equal to 2.5 times upper limits of normal ( no liver metastases); or ALT and/or AST greater than or equal to 5 times upper limits of normal (liver metastases). * Blood urea nitrogen(BUN) greater than or equal to 1.5 times upper limits of normal or Serum creatinine greater than or equal to 1.5 times upper limits of normal. * White blood cell(WBC) count\< 3.5×109/L or Absolute neutrophil count(ANC)\<1.5×109/L or platelet count\<75×109/L or Hemoglobin\<80g/L. * Human immunodeficiency virus (HIV) positive. * Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization. * Pregnant or nursing women. * Known central nervous system(CNS) metastases with B-CLL. * Active secondary malignancy. * cytomegalovirus(CMV) positive or immunodeficiency disease or after stem cell transplantation.
References
Publications (0)
Data not yet available
No reference posted for this study.