CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 50 target
Drug / intervention
FCR and Ibrutinib +2 moredrug
Likely dose
FCR and Ibrutinib 25mg/m2from record
Key inclusion· 17
  • ✓Age 18-75 years
  • ✓Confirmed CLL/SLL diagnosis by IWCLL criteria
  • ✓Treatment-naive or minimal prior therapy
  • ✓No prior combined chemotherapy (CHOP, COP, etc.)
Key exclusion· 16
  • ✕Malignancy other than CLL within past 1 year
  • ✕Active CNS involvement with lymphoma
  • ✕Transformation to large cell lymphoma
  • ✕Progression to prolymphocytic leukemia (PLL)

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

Search/NCT03980002
NCT03980002Phase 2RecruitingUpdate OverdueUpdated 84mo ago · Completion was 42mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With Chronic Lymphocytic Leukemia

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Jun 10, 2019·Updated Jun 10, 2019

In Brief

A Phase 2 clinical trial evaluating FCR and Ibrutinib, BR and Ibrutinib, and 1 other intervention for Chronic Lymphocytic Leukemia. Currently recruiting, targeting 50 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202020212022202320242025202620272028
First PostedJun 10, 2019
Enrollment StartMay 15, 2019
Primary CompletionDec 15, 2022
Study CompletionDec 30, 2027
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.1 years ago

Interventions

FCR and Ibrutinibdrug

Induction treatment: Patients \<65 y and without significant comorbidities are given FCR 1or 2 courses (If patients' white blood cell count \<10×10\^9/L after first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with FCR in 2 cylcles. 1. FCR： F（Fludarabine）：25mg/m2·d，d1-3； C（Cyclophosphamide）：CTX 250mg /m2·d，d1-3； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）； 2. Ibrutinib:420mg/d

BR and Ibrutinibdrug

Induction treatment: Patients ≥65y and ≤75 y or \<65 y but with comorbidities, are given BR 1or 2 courses (If patients' white blood cell count drop to below10×10\^9/Lafter first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with BR in 2 cylcles. 1.BR： B（Bendamustine）：90mg/m2·d，d1-2； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）； 2. Ibrutinib: 420mg/d

Ibrutinib and Thalidomidedrug

Maintenance treatment: After induction treatment, recommend ( but not mandatory) Ibrutinib or thalidomide monotherapy(according to patients preferrance) for MRD-positive patients.For MRD-negative patients, recommend ( but not mandatory) no maintenance therapy.