Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT02815059
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 420mg PO daily (dose level 0) or 560mg PO daily (dose level +1) administered Day 15 through day 90.
  • Dasatinib — DRUG
    Dasatinib 100mg PO daily (Day 1 through Day 90). Dasatinib dose will be increased to 140mg daily in patients tolerating dasatinib 100mg who have not achieved a complete bone marrow response (less than 5% blasts) by Day 22 or who have not achieved major molecular response by Day 43.
  • Prednisone — DRUG
    Prednisone 60mg/m2 PO daily (Day 1 through Day 32)

Study Details

This is a Phase I, single-center, open label, prospective, single-arm, dose-escalation and multi-dose study evaluating the use of ibrutinib in combination with dasatinib and prednisone therapy.

Key Dates

Start date
Sep 28, 2016
Status verified
Jan 2018
Primary completion
Jan 9, 2018
Completion
Jan 9, 2018

Study Design

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

Arms

  • Experimental: Ibrutinib, Dasatinib and prednisone, all patients

Primary Outcome Measure

Incidence of adverse events of combination of ibrutinib and dasatinib [ Time Frame: Patient safety will be evaluated throughout the treatment period (treatment with Ibrutinib and dasatinib which is expected to last 90 days for each patient) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Huntsman Cancer Institute· Salt Lake City, UT

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