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A phase 3 trial of Fludarabine, Cyclophosphamide, Rituximab and Pentostatin in Chronic lymphocytic leukaemia, run by US Oncology Research, completed.
Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients is a phase 3 interventional study registered as NCT00254163 by US Oncology Research, with 184 participants recorded, started 2003-12 and reaching its primary completion in 2011-09. Interventions recorded: Fludarabine, Cyclophosphamide, Rituximab, Pentostatin. Conditions recorded: B-Cell Chronic Lymphocytic Leukemia.
Linked to the drug Pentostatin because the registry names it among its interventions and Chronic lymphocytic leukaemia among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
184 enrolled.
95% CI 21.8 to 42.3; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication · 95% CI 26.3 to 47.6
Source95% CI 0.76 to 0.92; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication · 95% CI 0.74 to 0.90
Source95% CI 48.2 to 69.8; Figures from the ClinicalTrials.gov results section (first posted 2016-11-03), not from a publication · 95% CI 38.4 to 60.5
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Infection Rateprimary | FCR Arm | 86 | 31.4% | - | - | link |
| PCR Arm | 85 | 36.5% | ||||
| Progression-free Survival (PFS) Rate at 1-year | FCR Arm | 86 | 0.86 probability of progression-free survival | - | - | link |
| PCR Arm | 85 | 0.84 probability of progression-free survival | ||||
| Objective Remission Rate (ORR) | FCR Arm | 86 | 59.3% | - | - | link |
| PCR Arm | 85 | 49.4% |
Shares Fludarabine, Chronic lymphocytic leukaemia, first treatment, Rituximab, Cyclophosphamide and the tag pipeline.
Shares Pentostatin, Rituximab and the tag pipeline.
Shares Fludarabine, Cyclophosphamide and the tag pipeline.
Shares Fludarabine, Cyclophosphamide and the tag pipeline.
Shares Fludarabine, Cyclophosphamide, Chronic lymphocytic leukaemia and the tag pipeline.
Shares Chronic lymphocytic leukaemia, first treatment, Rituximab, Chronic lymphocytic leukaemia and the tag pipeline.
Shares Chronic lymphocytic leukaemia, first treatment, Rituximab, Chronic lymphocytic leukaemia and the tag pipeline.
Shares Fludarabine, Cyclophosphamide and the tag pipeline.