Clinical trial · Interventional
Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia in Partial Remission or Complete Remission
Eradication of Minimal Residual Disease (MRD) in Patients With Chronic Lymphocytic Leukaemia (CLL) With Alemtuzumab: A Phase II Study
- 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, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase II trial is studying the side effects and how well alemtuzumab works in treating patients with B-cell chronic lymphocytic leukemia in partial remission or complete remission.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Rate of undetectable minimal residual disease (MRD) after completion of alemtuzumab therapy
- measure
- Rate of unacceptable toxicities
Secondary outcomes (8)
- measure
- Rate of overall response (complete or partial response)
- measure
- Time to MRD relapse
- measure
- Overall survival
- measure
- Expression of CD52 on chronic lymphocytic leukemia cells
- measure
- Rate of re-achievement of MRD negativity after completion of alemtuzumab therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) meeting the following criterion: * Confirmed by characteristic immunophenotype on peripheral blood flow cytometry * In complete or partial remission after prior therapy for B-CLL * No treatment failure after receiving prior alemtuzumab therapy * Minimal residual disease (MRD) status meeting 1 of the following criteria: * Detectable B-CLL MRD (i.e., MRD-positive) as shown by peripheral blood or bone marrow involvement * Undetectable B-CLL MRD (i.e., MRD-negative remission) * Lymph nodes \< 2 cm in maximum diameter * No persisting severe pancytopenia due to prior therapy rather than disease, as defined by the following criteria: * Neutrophil count \< 5,000/mm\^3 * Platelet count \< 50,000/mm\^3 * No clinically progressive disease (i.e., peripheral blood B-cell count ≥ 5,000/mm³) * No mantle cell lymphoma * No CNS involvement with B-CLL PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * Creatinine \< 2 times upper limit of normal (ULN)\* * Bilirubin \< 2 times ULN\* * No known HIV positivity * No concurrent active infection * No history of anaphylaxis after exposure to rat or mouse-derived, complementary-determining region-grafted humanized monoclonal antibodies * No other concurrent severe diseases or mental disorders * No concurrent active secondary malignancy NOTE: \*Unless secondary to direct infiltration of the liver by B-CLL or hemolysis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior allogeneic stem cell transplantation * Any other prior therapy allowed * At least 6 months since completion of last therapy for B-CLL * More than 6 weeks since prior investigational agents * No other concurrent cytotoxic agents
References
Publications (0)
Data not yet available