Phase 2
Completed N=66
Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline
Source: ClinicalTrials.gov NCT00794820 ↗Enrolled (actual)
66
Serious AEs
46.2%
Results posted
Aug 2016
Primary outcomePrimary: Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months — 75 Percentage of Participants
Summary
Primary Objective:
* To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL.
Secondary Objective:
* To evaluate remission duration and survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months |
75 | — |
| SECONDARY Remission Duration/Time to Progression (TTP) |
81 | — |
| SECONDARY Overall Survival (OS) Rate |
58 | — |
Eligibility Criteria
Inclusion Criteria
- 16 years or older
- Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month of steroids or chemotherapy) are eligible
- Performance status of 3 or better (Appendix A)
- Adequate renal and hepatic function (creatinine <2 mg%, bilirubin <2mg%). Patient with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman but upper limits for creatinine even under these circumstances would be creatinine < 3 mg% and bilirubin < 6 mg%. Patients with Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%..
- A signed informed consent in keeping with policies of the hospital
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00794820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.