Duvelisib With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO)

Part of paid clinical trials in Miami, Florida.

Sponsor
SecuraBio
Study ID
NCT02605694
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Duvelisib — DRUG
    25 mg will be administered orally twice daily (BID) during 21-day cycles (Cycles 1-6) followed by 28-day cycles (Cycle 7 and beyond) until disease progression or unacceptable toxicity
  • Rituximab — DRUG
    375 mg/m2 will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).
  • R-CHOP — DRUG
    IV infusion on Day 1 of Cycles 1-6 (21-day cycles) * Cyclophosphamide (750 mg/m2) * Doxorubicin hydrochloride (50 mg/m2) * Vincristine sulfate (1.4 mg/m2) (2 mg maximum) * Rituximab (375 mg/m2)
  • Prednisone — DRUG
    100 mg orally on Days 1-5 of Cycles 1-6 (21-day cycles)

Study Details

Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with relapsed/refractory FL

Key Dates

Start date
Dec 31, 2015
Status verified
Mar 2021
Primary completion
Nov 30, 2016
Completion
Nov 30, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Duvelisib 25 mg will be administered orally twice daily (BID) during 21-day cycles (Cycles 1-6) followed by 28-day cycles (Cycle 7 and beyond) until disease progression or unacceptable toxicity; and Rituximab (375 mg/m2) will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).
  • Active Comparator: Arm 2
    R-CHOP will be administered as follows: IV infusion on Day 1 of Cycles 1-6 (21-day cycles) * Cyclophosphamide (750 mg/m2) * Doxorubicin hydrochloride (50 mg/m2) * Vincristine sulfate (1.4 mg/m2) (2 mg maximum) * Rituximab (375 mg/m2) Orally on Days 1-5 of Cycles 1-6 (21-day cycles) * Prednisone (100 mg) will be administered.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Time from randomization to documented disease progression, or death due to any cause, whatever comes first, assessed up to approximately 44 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
-MiamiFlorida33133-

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