Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase II Trial of Rituximab/Fludarabine Followed by CAMPATH-1H in the First-Line Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193466

Enrollment

Registered

2005-09-19

Start date

2002-01-31

Completion date

2008-04-30

Last updated

2010-12-30

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

Conditions

Non-Hodgkins Lymphoma

Brief summary

In this multicenter trial, we will investigate the use of fludarabine plus rituximab, followed by Campath-1H, in previously untreated patients with CLL/SLL. Patients who are elderly, or who are considered unlikely to tolerate this combination therapy well, will receive single agent rituximab followed by Campath-1H.

Detailed description

Upon determination of eligibility, all patients will receive: Fludarabine + Rituximab + CAMPATH-1H Patients who are judged by the investigator not to be candidates for fludarabine due to advanced age, marginal performance status or coexistent medical conditions will receive rituximab alone followed by CAMPATH-1H.

Interventions

DRUGRituximab

DRUGFludarabine

DRUGCAMPTH-1H

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria: * Histologically proven B-cell CLL/SLL * Positive staining for CD20 antigen * No systemic chemotherapy. * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Age \> 18 years * Life expectancy \> 12 weeks * Adequate liver and kidney function * Must be accessible for treatment and follow-up * Must give written informed consent prior to entering this study.

Exclusion criteria

You cannot participate in this study if any of the following apply to you: * Female pregnant or lactating * Unstabilized active infection on the basis of neutropenia * History of previous severe opportunistic infections * Serious underlying medical conditions * Central nervous system involvement * History of other neoplasms, either active or treated within five years Please note: There are additional inclusion/

Design outcomes

Primary

Measure	Time frame
Complete response rate	—

Secondary

Measure	Time frame
Molecular complete response rate	—
Progression free survival	—
Overall toxicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026