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

Non-Hodgkins Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193466
• Other study ID #: SCRI LYM 21
• Secondary ID: CAM-217
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 29, 2010
• Start date: January 2002
• Est. completion date: April 2008

Study information

• Verified date: December 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

Drug:
• Rituximab

• Fludarabine

• CAMPTH-1H

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Bayer

References & Publications (1)

Hainsworth JD, Vazquez ER, Spigel DR, Raefsky E, Bearden JD, Saez RA, Greco FA. Combination therapy with fludarabine and rituximab followed by alemtuzumab in the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate
Secondary	Molecular complete response rate
Secondary	Progression free survival
Secondary	Overall toxicity

External Links

•   Published in Cancer