Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine

Subcutaneous Campath-1H in Fludarabine-Refractory CLL

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274976

Enrollment

Unknown

Registered

2006-01-11

Start date

2002-09-30

Completion date

2009-08-31

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Brief summary

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 how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.

Detailed description

OBJECTIVES: * Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia. * Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain \[IgVH\] status, del \[17p\], del \[11q\]) treated with subcutaneous alemtuzumab after progression on fludarabine. OUTLINE: This is a multicenter study. Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Interventions

BIOLOGICALalemtuzumab

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL) * Fludarabine-refractory disease * Requires treatment PATIENT CHARACTERISTICS: * Life expectancy more than 6 months * ECOG 0-2 * No severe organ dysfunction * No other concomitant or previous neoplasms * No autoimmune hemolytic anemia or thrombocytopenia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Up to 5 prior chemotherapy regimens allowed

Design outcomes

Primary

Measure	Time frame
Safety and efficacy	—
Response	—

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026