CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
filgrastim +3 morebiological
Likely dose
Fludarabine 25 mg/m² IV daily × 5 days every 4 weeks; Cyclophosphamide 3000 mg/m² IV every 2-3 weeks × 3 doses; Rituximab 375 mg/m² IV weekly × 4 dosesAI-extracted
Key inclusion· 8
  • ✓Intermediate or high-risk CLL by Rai system (or Rai intermediate with active disease per NCI Working Group criteria)
  • ✓Previously untreated with cytoreductive agents
  • ✓Absolute lymphocytosis ≥5,000/μL or bone marrow lymphocytosis ≥30% with CD5 and CD20 expression
  • ✓Age 18-75 years
Key exclusion· 8
  • ✕Rai intermediate risk 'smouldering leukemia' per Montserrat criteria
  • ✕Significant autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • ✕Active infections requiring systemic antibiotics
  • ✕Prior cytotoxic treatment for CLL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003659
NCT00003659Phase 2Completed
CompareCT.gov

A Phase II Study of Fludarabine Induction With Sequential High Dose Cyclophosphamide and Rituximab as Consolidation Therapy for Previously Untreated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 27, 2003·Updated Oct 24, 2017

In Brief

A Phase 2 clinical trial evaluating filgrastim, rituximab, and 2 other interventions for Leukemia. Completed, enrolled 39 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose cyclophosphamide and rituximab in treating patients who have previously untreated chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 1998
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

Filgrastim (300 μg for patients ≤ 70 kg or 480 μg for patients \> 70 kg) will be administered beginning two days after each cyclophosphamide dose and given for a total of eight subcutaneous daily doses.

rituximabbiological

Approximately four weeks after the completion of the last cyclophosphamide dose, patients will receive rituximab 375mg/m2 as an intravenous infusion once weekly for four doses.

cyclophosphamidedrug

Cyclophosphamide 3000mg/m2 will be given intravenously q 2 - 3 weeks x 3 doses.

fludarabine phosphatedrug

Fludarabine will be administered intravenously at a dose of 25 mg/m2 per day x 5 days every 4 weeks.