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)
2 other identifiers
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2002
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 30, 2010
December 1, 2010
5 years
September 12, 2005
December 29, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response rate
Secondary Outcomes (3)
Molecular complete response rate
Progression free survival
Overall toxicity
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bayercollaborator
Related 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 lymphoma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Mar 15;112(6):1288-95. doi: 10.1002/cncr.23271.
PMID: 18189296RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
January 1, 2002
Primary Completion
January 1, 2007
Study Completion
April 1, 2008
Last Updated
December 30, 2010
Record last verified: 2010-12