Clinical trial · Interventional
Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia
Antibody Therapy With Alemtuzumab and Rituximab for Initial Treatment of High Risk Chronic Lymphocytic Leukemia
- 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 and rituximab, 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. Giving alemtuzumab together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving alemtuzumab together with rituximab works in treating patients with high-risk, early-stage 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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab + Rituximab
- description
- Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
- interventionNames
- Drug: Alemtuzumab
- Drug: Rituximab
Primary outcomes (2)
- measure
- Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months
- timeFrame
- Up to 6 months
- description
- Confirmed response is defined as a \> 50% decrease in clinical symptoms from baseline and recovery from blood counts.
- measure
- Number of Participants With Treatment Related Adverse Events
- timeFrame
- Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: \* Diagnosis of B-cell chronic lymphocytic leukemia (CLL) \- Early-stage, biologically high-risk disease defined by the following criteria: * Rai stage 0-II (does not meet standard NCI-sponsored Working Group criteria for treatment) * Clinical and phenotypic features manifested in the peripheral blood, including the following: * Minimum threshold peripheral blood lymphocyte count of \> 5,000/mm³ * Small-to-moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes * Monoclonality of B lymphocytes by immunophenotypic evaluation, demonstrating co-expression of CD19, CD5, and CD23 antigens, surface expression of CD20 and CD52, and B-cell monoclonal population defined by light-chain exclusions * Poor prognosis demonstrated by ≥ 1 of the following high-risk parameters: * Unmutated human immunoglobulin variable region heavy chain (IgVH) gene and CD38 expression (≥ 30% cells positive on flow cytometry) OR unmutated IgVH ZAP-70 expression (≥ 20% cells positive on flow cytometry) = 11q- = 17p- PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN * AST ≤ 3.0 times ULN (unless due to hemolysis or CLL) * Hemoglobin ≥ 9.0 g/dL * No New York Heart Association class III-IV heart disease * No myocardial infarction within the past month * No uncontrolled infection * No active HIV infection * No evidence of autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia * No other active primary malignancy requiring treatment or limiting survival to less than 2 years PRIOR CONCURRENT THERAPY: * No prior treatment for CLL * Prior corticosteroids allowed * No prior radiotherapy * More than 4 weeks since prior major surgery
References
Publications (2)
- RESULTZent CS, Call TG, Shanafelt TD, Tschumper RC, Jelinek DF, Bowen DA, Secreto CR, Laplant BR, Kabat BF, Kay NE. Early treatment of high-risk chronic lymphocytic leukemia with alemtuzumab and rituximab. Cancer. 2008 Oct 15;113(8):2110-8. doi: 10.1002/cncr.23824. PMID 18759253
- RESULTZent CS, Secreto CR, LaPlant BR, Bone ND, Call TG, Shanafelt TD, Jelinek DF, Tschumper RC, Kay NE. Direct and complement dependent cytotoxicity in CLL cells from patients with high-risk early-intermediate stage chronic lymphocytic leukemia (CLL) treated with alemtuzumab and rituximab. Leuk Res. 2008 Dec;32(12):1849-56. doi: 10.1016/j.leukres.2008.05.014. Epub 2008 Jun 27. PMID 18584865