A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02251548
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Oral BTK inhibitor
  • Fludarabine — DRUG
    IV purine analogue chemotherapy agent
  • Cyclophosphamide — DRUG
    IV alkylator chemotherapy agent
  • Rituximab — DRUG
    IV anti-CD20 monoclonal antibody

Study Details

This research study is evaluating a new drug called ibrutinib in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

Key Dates

Start date
Oct 31, 2014
Status verified
Sep 2025
Primary completion
Jan 31, 2025
Completion
Jan 31, 2027

Study Design

Enrollment
85 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib
    \- Ibrutinib- * Oral, daily during each cycle * fludarabine-administered at standard dosing for up to 6 cycles * cyclophosphamide-administered at standard dosing for up to 6 cycles * rituximab-administered at standard dosing for up to 6 cycles

Primary Outcome Measure

Part I: Participants Who Achieve a Minimal Residual Disease (MRD) Negative Complete Response (CR) in the Bone Marrow at 2 Months Post FCR [ Time Frame: 2 months after completing combination therapy ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterCoral GablesFlorida33146-
University of Miami Sylvester Comprehensive Cancer CenterDeerfield BeachFlorida33442-
Unversity of Miami Sylvester Comprehensve Cancer CenterMiamiFlorida33136-
University of Kansas Cancer CenterWestwoodKansas66205-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
West Michigan Cancer CenterKalamazooMichigan49007-
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Coral Gables, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami Sylvester Comprehensive Cancer Center· Coral Gables, FLUniversity of Miami Sylvester Comprehensive Cancer Center· Deerfield Beach, FLUnversity of Miami Sylvester Comprehensve Cancer Center· Miami, FLUniversity of Kansas Cancer Center· Westwood, KSBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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