A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT02514083
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 420mg PO daily for the duration of the study.
  • Fludarabine — DRUG
    Fludarabine 25 mg/m2/day IV on days 1-5 of cycles 3 and 4

Study Details

This is a pilot phase 2 study investigating the safety and efficacy of ibrutinib combined with short-course fludarabine in previously untreated CLL patients. Ibrutinib will be given daily until disease progression or intolerable side effects occur. Fludarabine will be given in cycles 3 and 4. The primary efficacy endpoint is the rate of complete response after 6 cycles or 24 weeks. The primary safety endpoint is the rate of treatment discontinuation after 6 cycles or 24 weeks.

Key Dates

Start date
Dec 9, 2015
Status verified
Mar 2026
Primary completion
Oct 2, 2019
Completion
Oct 23, 2034

Study Design

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

Arms

  • Experimental: Ibrutinib and short-course fludarabine
    * Ibrutinib 420 mg PO daily for the duration of the study * Fludarabine 25 mg/m2/day IV on days 1-5 of cycles 3 and 4

Primary Outcome Measure

Rate of Complete Response at 24 Weeks [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By research site
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