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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkins Lymphoma

Treatments

Drug: Rituximab

Drug: Fludarabine

Drug: CAMPTH-1H

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193466

CAM-217

SCRI LYM 21

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.