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Anti-metabolites

Laboratory Biomarker Analysis for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By John C Byrd
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing how well fludarabine and rituximab work when given with or without lenalidomide or cyclophosphamide to treat patients with symptomatic chronic lymphocytic leukemia.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2-Year Progression Free Survival (PFS) Rate
Secondary outcome measures
Overall Response Rate in Patients Without Del(11q22.3)
Overall Response Rates in Patients With Del(11q22.3)
PFS Rate of Patients With Del(11q22.3)
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (rituximab, fludarabine, cyclophosphamide, lenalidomide)Experimental Treatment5 Interventions
Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
Group II: Arm C (rituximab, fludarabine phosphate, cyclophosphamide)Experimental Treatment4 Interventions
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
Group III: Arm B (rituximab, fludarabine phosphate, lenalidomide)Experimental Treatment4 Interventions
Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
Group IV: Arm A (rituximab, fludarabine phosphate)Active Control3 Interventions
Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Lenalidomide
2005
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
261,393 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,249 Total Patients Enrolled
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
150,412 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment slots still available for this investigation?

"Clinicialtrials.gov confirms that this trial, which was created on the 15th of January 2008 and last updated on September 23rd 2022, is no longer accepting enrollees. However, 2862 other medical studies are still taking participants at present time."

Answered by AI

How many participants are being monitored as part of this research?

"At this moment, no additional candidates are being sought for the trial. This clinical study was initially listed on January 15th 2008 and has been recently revised on September 23rd 2022. If you are seeking alternative trials, there are presently 1,516 opportunities for patients suffering from leukemia and 1,346 studies related to Laboratory Biomarker Analysis searching for participants."

Answered by AI

Has Laboratory Biomarker Analysis been employed in other research endeavors?

"Currently, 1346 Laboratory Biomarker Analysis studies are in progress. 265 of these investigations belong to Phase 3 and have been conducted across 46368 sites globally, with the majority situated near Philadelphia, Pennsylvania."

Answered by AI

What health conditions are typically addressed with Laboratory Biomarker Analysis?

"Leukemia is routinely treated with Laboratory Biomarker Analysis, and this approach has also been proven to benefit those afflicted by Chronic Lymphocytic Leukaemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), as well as two or more prior systemic chemotherapy treatments."

Answered by AI

How many sites have been approved to conduct this research experiment?

"This clinical trial is being administered from Holy Family Medical Center in Monmouth, Indiana; Ottawa Regional Hospital and Healthcare Center located in Ottawa, Maryland; Perry Memorial Hospital based out of Princeton, Michigan; as well as 100 additional sites."

Answered by AI

Has Laboratory Biomarker Analysis achieved regulatory clearance from the FDA?

"There is some evidence of safety, yet no data to suggest efficacy; thus Laboratory Biomarker Analysis was assigned a rating of 2 on our team's scale."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Maryland
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
2008. "Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00602459.
~24 spots leftby Apr 2025
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